Quality & Regulatory Jobs in Pharma & Biotech

The Associate Director, Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China) . Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. May manage direct reports. What You’ll Do Responsible for developing and executing global regulatory strategies...

The Regional Distribution Quality Specialist is responsible for ensuring the quality of distribution operations across the Americas, focusing on warehousing, order fulfillment, product returns, and value-added services such as labeling, boxing and recharging. This role will provide quality support and oversight to ensure compliance with internal and external regulations, standards, and guidelines, specifically ISO 13485, and 21 CFR 820, across multiple 3PL distribution centers in the Americas in support of Medtronic Minimed. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation...

About This Role As the US Regulatory Lead, you will be responsible for developing and executing US regulatory strategies as part of the Global Regulatory Affairs team. You will also oversee the preparation, submission, and management of regulatory filings interactions with the FDA. This role requires outstanding collaboration abilities, as you will play a key role in proactively identifying regulatory risks and developing mitigation strategies ensuring compliance with relevant regulatory requirements, company policies, and industry standards, ensuring impactful outcomes and solutions for patients. This is a hybrid role, requiring 3 days office attendance per week. What You’ll Do Direct US...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Assist the Global Inflammation Regulatory Affairs Liaison team with projects to support department goals and objectives. Interns will assist with regulatory submissions and activities, including but not limited to potential submission of clinical study reports, study protocols and protocol amendments, and assist with activities in preparation for...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Oncology Products Policy Research (75%) Conduct research on novel and innovative oncology approaches, including topics such as the contribution of components in PD-L1 combination strategies, validation methods for novel endpoints, and biomarker investigations. Draft science-based articles intended for review, consideration, and presentation to regulatory agencies. Regulatory Intelligence...

As a Talent Acquisition Compliance Specialist on the Operations and Innovation team, you will focus on TA Compliance reporting to the TA Compliance Lead. This position will be responsible for all facets in compliance with internal hiring guidelines, pre-employment requirements such as background checks and external regulations set by EEOC and OFCCP. Key Responsibilities Responsible for maintaining Offer Compliance including adherence to compensation guidelines and documentation including Letters and Employee Agreements for pre employment compliance Serve as Talent Acquisition’s subject matter expert in the offer preparation process including working closely with Total Rewards, Recruiters, and Candidates Serve as Talent Acquisition’s...

Mission The mission of the Oncology and Specialty Regulatory Affairs Specialist is to be responsible for the regulatory activities related to oncology and specialty products in Paraguay and Uruguay, aligned to business needs, to assure compliance with local regulations and with AbbVie policies. The Co-technical director is AbbVie’s representative before the regulatory authorities in Uruguay as well as the link with the representative in Paraguay. Main responsibilities 1. Regulatory Affairs activities Devise regulatory strategies, aligned within the Brand Team, for successfully registering oncology and specialty products in Uruguay and Paraguay. Be AbbVie’s representative before the MSP (local HA)...

Positions Summary The Manager, Quality Assurance Disposition Support, Devens Cell Therapy role is responsible for the support of the overall Devens Disposition organization, inclusive of systems, metrics, Quality System Records, and deployment of priority projects. This individual will provide support to all functions reporting through the Quality Disposition organization, including incoming materials QA and disposition, systems, drug product disposition, and Material Review Board. This individual will provide oversight of projects with Disposition impact, APQR data compilation, Disposition metrics, CAPAs owned by Disposition, Deviations owned by Disposition, Change Control Impact Assessments, Change Controls owned by Disposition, product and will perform routine...

PRINCIPAL OBJECTIVE OF THE POSITION Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. Major Duties and Responsibilities Quality floor support of complex manufacturing activities Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas...

Material Compliance Associate What you will do In this vital role you will be responsible to assist the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect “live” edits during compliance review/approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process. Responsibilities Quality check submissions for review to ensure alignment with internal standards Work with agencies and internal staff, including training on next...

Use Your Power for Purpose At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. What You Will Achieve In this role, you will Lead the completion of assigned complex projects, meet agreed targets and develop plans for work activities on...

Position Overview We are seeking a strategic leader to establish and lead our new Regulatory Intelligence organization. The Sr. Director, Head of Regulatory Intelligence will set the strategic direction for the team, oversee the integration of regulatory insights into organizational decision-making, and represent the organization at the highest levels. This role is pivotal in shaping our regulatory intelligence strategy, setting key initiatives, and delivering actionable insights on emerging regulatory guidance and health authority enforcement trends. Key Responsibilities Set strategic direction and priorities for the Regulatory Intelligence team to ensure alignment with organizational goals. Represent the organization at the executive level,...

Employer Johnson & Johnson Health Care

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our Team in Spring House, PA. This position is part of the Site Engineering Team, which is the asset-management team consisting...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a hybrid role and can be located in Raritan, NJ or Spring House, PA. Remote work options may be considered...

The Associate Director, Quality Control within our Research and Development Division Device Quality & Regulatory is responsible for providing QA/QC oversight of the company's Device Network design verification laboratories. This role will provide quality oversight for the qualification, calibration and maintenance of analytical laboratory instruments and equipment, method validation, and associated documentation for design verification laboratories in Rahway and the Center for Packaging & Device Analytics (CPDA). Key responsibilities include 1. Serve as quality oversight for design verification laboratories Quality oversight for qualification, maintenance and calibration of laboratory equipment, instrumentation and test methods used to support design verification. Provides quality...

In this exciting role as an Audit Compliance Manager, you will have responsibility for leading the compliance audit program for the Medtronic Diabetes business. The Audit Compliance Manager is responsible for managing the compliance audit program, for internal, external and supplier audits at the Diabetes sites. This position is an exciting opportunity to work with Medtronic's Diabetes business. This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. The individual in this role must be comfortable coaching all employees on audit readiness and working professionally with others to...

This individual will be part of the Operations legal team and must possess deep substantive expertise in global trade areas core to the Medtronic Diabetes business. This role will work across geographies resulting in unique ability to 1) advise on complex legal regulatory questions, 2) identify common and conflicting legal issues and positions across the company, and 3) contribute to high-level policy decision-making. This individual will provide import and customs compliance advice to help mitigate risks and provide support to Global Trade Operations, global regional and business unit lawyers, and other relevant functions. Specific global trade areas of legal and...

The Quality Software Engineer II is an established individual contributor responsible for ensuring software systems meet rigorous quality standards throughout the development lifecycle. This role involves defining, implementing, and maintaining quality processes, conducting evaluations, and supporting verification and validation activities to ensure compliance with project, process, and contractual requirements. A strong background in robotics and experience analyzing software logs for quality and reliability are highly valued. Responsibilities Perform detailed software log reviews to identify anomalies, ensure compliance, and improve system reliability. Collaborate with cross-functional teams, including robotics engineers, to achieve quality objectives and project milestones. Develop, modify, apply, and maintain...

The Director, Regulatory Programs will join our Global Regulatory Operations team and lead portfolio management of regulatory programs across medical device business units, international regulatory teams, and global regulatory operations. This role provides strategic leadership and stewardship to ensure alignment with division strategies and business objectives. The Director will be responsible for developing, maintaining, and reporting on timelines, budgets, and regulatory activity tracking. Additionally, they will lead initiatives aimed at improving efficiency and effectiveness within regulatory processes. By applying best practices in program management, the Director will help achieve—and exceed—medical device division goals. This position serves as the primary point...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following This position provides essential support across all areas of the IT Risk & Compliance program. The internship offers hands-on experience in IT Security, Risk, and Compliance activities, including exposure to governance frameworks, regulatory requirements, and enterprise risk management practices. Interns will gain practical knowledge of industry standards...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Supporting activities related to Packaging and Labeling of Phase 1 materials in Foster City Helping develop process flow maps Developing manufacturing instructions for labeling Supporting SOP and WRK instruction updates or creation Showcase your work with a final presentation (PPT) near the conclusion of your internship Required...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Create custom innovation solutions using different artificial intelligence, analytics and automation platforms to solve business problems and inefficiencies. Work closely with SMEs and leaders in various functions within Regulatory, Safety and Quality to understand and identify routine, repetitive process steps that could be improved using various technologies....

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Train on Human and Organizational Performance principles and problem solving/predicting tools (Ex. Systems Model Analysis approach) Work with VP CQO and identified stakeholders to further develop and execute against the overall strategy to build capability within PDM and embed within problem solving, change control, and risk frameworks...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Work as a member of the IT Quality Assurance (QA) team, and collaborate with IT engineering functions, to Develop data-driven solutions that enhance IT QA operational efficiency and decision-making. Develop solutions that support the automation of IT QA manual processes using technologies such as Blue Prism, Microsoft...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead Sciences. The candidate should be enrolled in an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The summer...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Research and document the full QC product lifecycle activities, including method validations and transfers, specification establishment, reference standard and critical reagent management, and the responsibilities of a QC product lead. Interview subject matter experts (SMEs) within QC and across departments to gather process details and pain points....

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following The Office of Ethics and Compliance Intern will assist in a variety of initiatives that strengthen our ethical culture and compliance framework. The intern may be involved in areas such as compliance training development, systems and analytics projects, transparency reporting operations, data privacy activities, and integrated risk...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Position supports the Analysis of Development and Commercial project actual and forecast data improving overall predictive modeling, reporting and cross-functional collaboration. Position requires skills in analyzing large set of data and willingness to reach out to a large set of stakeholders to advance Projects Analysis work in...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include but not limited to the following Independently support development and execute GMP method validation. Run experiments according to test methods, specifications, and protocols. Execute laboratory techniques such as Water Content by Karl Fischer, Dissolution and Liquid Chromatography. Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts. Participate in meetings, present and interpret data. Conduct...

Typical Accountabilities Accountable for the development and implementation of the regulatory strategy for a product/ group of products, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients Accountable for product maintenance, supply and compliance activities associated with marketed brands Delivers all regulatory milestones including assessment of the approvability of the program together with risk mitigation measures Leads the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation...

KEY RESPONSIBILITIES The Senior Director, Quality Policy and Advocacy is a recognized expert both inside and outside the business and is responsible for leading various global aspects of internal and external-facing advocacy as applicable to support the Gilead portfolio. This leader will represent the business externally and will be focused on influencing while developing and advocating policy positions (internally and externally) for Quality Policy issues in conjunction with the Gilead CMC Regulatory Policy Office. The role will be focused primarily on the North American policy landscape, with appropriate alignment and involvement in the global policy landscape and will be responsible...

ETHICON, Inc., a member of Johnson & Johnson's Family of Companies and located in Cornelia, Georgia, is recruiting current college students for their Engineering Co-op Program. This position is designed for current college students. The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy...

SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions for both the Americas and the EU....

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. Envisions the future by using global marketplace, technology and business knowledge. Collects and analyzes issues and trends that affect the business. Identifies and acts upon cross-organization or cross-business opportunities. Possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and future business needs....

About GenerateBiomedicines GenerateBiomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform...

The Sr Quality Engineer is responsible for ensuring the quality and safety of our genomic products and services by assisting in the maintenance of the quality management system (QMS) that complies with ISO 13485 and ISO 14971. This position is also responsible for conducting risk assessments, developing, and implementing corrective actions, and providing technical support to the R&D team. What You’ll Be Doing Maintain a QMS that complies with ISO 13485 and ISO 14971. Conduct risk assessments to identify and assess potential hazards associated with genomic products and services. Develop and implement corrective actions to address identified hazards and prevent...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Senior Director of Quality Management System Health and Capability...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. urpose The purpose of the Senior Director – GPS Safety Data...

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Compliance Engineer located in Santa Clara, CA. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics and Digital Solutions was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in...

The Information Security Governance, Risk & Compliance (GRC) Director is responsible for leading and maturing the company’s global security governance framework, enterprise cyber risk management program, and compliance activities across IT, OT, cloud, and regulated medical device environments. This leader ensures alignment with cybersecurity expectations, Quality System requirements, and industry best practices. The Director partners closely with IT, R&D, Operations, Legal/Privacy, Quality & Regulatory (QARA), and Internal Audit to strengthen the company’s security posture, reduce enterprise risk, and ensure readiness for audits, inspections, and regulatory submissions. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has...

We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle. Develop and maintain comprehensive strategies for risk management activities, including Creating and managing risk management plans and reports, as well as conducting regular risk reviews. Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures. Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential...

Step into a pivotal role where you’ll be at the heart of our advanced manufacturing environment, safeguarding both product quality and patient safety. As a leader in the Environment and Microbial disciplines, you’ll ensure our operations not only meet—but exceed—regulatory standards. You’ll have the opportunity to perform specialized microbial testing and orchestrate the dynamic activities of the microbial laboratory. This is your chance to make a direct impact, driving excellence and innovation across our manufacturing processes, while collaborating with a passionate team dedicated to improving lives. Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting...

The incumbent will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group that has global responsibility for microbial control and sterility assurance related topics. In the Associate director role, the incumbent will provide subject matter expertise for microbiology and/or virology related topics in biologic, vaccine sterile, non-sterile manufacturing and/or testing laboratories for assigned topics. Supports the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our Manufacturing Division is compliant to cGMPs for these topics. Supports divisional projects across internal and external sites. Supports development of strategy to drive compliance...

The incumbent will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group that has global responsibility for microbial control and sterility assurance related topics. In the Associate Director role, the incumbent will provide subject matter expertise for microbiology and/or virology related topics in biologic, vaccine sterile, non-sterile manufacturing and/or testing laboratories for assigned topics. Supports the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our company is compliant to cGMPs for these topics. Supports divisional projects across internal and external sites. Supports development of strategy to drive compliance and...

Personalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we‘re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world’s #1 continuous glucose monitoring (CGM)...

Sr. Manager, Supplier Quality This role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for keeping all the QS elements consistent and effective for its purpose. Ensures implementation of TPM related Quality Assurance policies and procedures generated conform to predetermined Corporate/Division standards and specifications. What You'll Work On Manage the Quality System for US third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance, systems include Nonconformance and CAPA Change control ...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. Bristol Myers Squibb is seeking a Manager, QC Sample Management at the Cell Therapy Facility (CTF) in Devens, MA. This role...

careers.bms.com/working-with-us To lead the simplification of the QA oversight process. The role will evaluate and identify key fields from existing QA interventions that should be the focus by QA oversight, instead of evaluating the whole process. The role will involve leveraging inputs such as improvement of the QA Oversight process and streamline the QA intervention process. Program dates June 1, 2026 – August 7, 2026. The hourly compensation for this assignment is $15/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not BMS). Factors influencing this decision...

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Principal Regulatory Compliance - Lead Auditor to be in Danvers, Massachusetts The position of the Principal Regulatory Compliance is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements. The Principal Regulatory Compliance...

Sitting in the Diabetes Regulatory Operations Team, the Regulatory Operations Specialist will be a key member managing regulatory data attributes, distribution control mechanisms, and preparation and publishing of submissions. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity,...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

The Senior Quality Engineer will play a critical role in driving quality systems improvements and ensuring compliance with regulatory requirements. This position is responsible for leading CAPAs, managing quality improvement projects and collaborating across departments to enhance product quality and process effectiveness. The ideal candidate will possess strong leadership skills, technical expertise, and a passion for delivering exceptional results. This role is 100% onsite at our Rice Creek, MN site. Responsibilities may include the following and other duties may be assigned Manage CAPA lifecycle, including root cause analysis, corrective action implementation, and preventive measures and ensure timely completion. Plan, execute...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Software Reliability Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Will monitor and approve cleanings for the manufacturing rooms and equipment...

Undergrad Co-op - Quality, Manufacturing, Operations and/or Engineering What You Will Do Ready to make an impact? Join us in redefining the world through innovation! We are offering multiple co-op opportunities starting in January 2026. As a co-op, you'll collaborate with cross-functional teams, gaining hands-on experience and advancing your professional skills. You’ll work on meaningful projects and initiatives, contributing to the team’s success while developing your own potential in our Operations organization centralized in Puerto Rico's End-to-End Manufacturing Site. Measure and analyze current system and process performance. Drive improvements in operational efficiency and productivity across the organization, maximizing AI and...

Location Remote Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Build and manage a Regulatory Operations team to support submission planning, publishing, and lifecycle management. Oversee/lead planning, tracking, publishing, compilation, and archiving efforts in support of regulatory submission activities including INDs, NDAs, BLAs, IND amendments, IMPDs and CTA submissions, EU and Rest of World (ROW) submissions. Lead the implementation and optimization of Veeva Vault RIMs, ensuring alignment with regulatory and business needs. Establish and maintain SOPs, work instructions, and best practices for regulatory operations. Monitor global regulatory operations requirements and ensure compliance with evolving...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care Responsibilities may include the following and other duties may be assigned. Shift ...

Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system. Understand Regulations and business processes required to maintain Laboratory Data Integrity. Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements. Adhere to cGMP requirements. Adhere to and supports all EHS & E standards, procedures and policies. Responsible for the timely completion of assigned laboratory testing. Ensure that all test equipment is used and maintained correctly. Able to work independently under minimal supervision. Perform environmental...

Performs quality laboratory testing required for the manufacturing process, utilities, raw materials, in process samples and final product following specifications in both the microbiological and analytical laboratories. Performs microbiological and analytical testing such as bio burden, endotoxin, TOC, pH and conductivity to water samples used in the product manufacturing process and to the final product. Performs in process product testing such as bio burden, and endotoxin and analytical testing (HPLC, Gel Electrophoresis, DNA), among others. Performs other microbiological lab testing such as growth promotion and identification of microorganisms. Provides support in method transfer, equipment/instrument qualification and process validation. Understand Regulations...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

Senior Manager, Global Compliance Operations will report to the Senior Director, Head of Global Compliance Operations and is a great opportunity for a highly motivated individual who is interested in independently managing critical components of the Compliance program in a dynamic and fast paced environment. This role requires strong attention to detail, professionalism, sound judgement, and the ability to work cross functionally with multiple stakeholders. The Opportunity to Make a Difference This role is responsible for executing tasks and initiatives that span all three pillars of Sarepta’s Global Compliance Program. The successful candidate will contribute to activities supporting Global Healthcare...