Principal QA Lead — Cell Therapy & Regulatory Submissions
Lyell Immunopharma
Lyell Immunopharma is seeking a Principal, Quality Assurance to lead QA oversight across the cell therapy product lifecycle. Based in Bothell, WA, you will partner with Manufacturing, MSAT, Process Development and Regulatory to support process validation, tech transfer and regulatory submissions. You will serve as Quality SME for IND/BLA coordination, author and review CMC sections, and ensure inspection readiness with a focus on continuous improvement and robust validation strategies. #J-18808-Ljbffr Lyell Immunopharma
$170k - $210.64k
...in-class targeted cancer therapies. We are advancing an innovative... ...the company, they will lead the discovery,... ...preparation and review of regulatory documents, including IND submissions, ensuring compliance with... ...Qualifications Ph.D. in Cell Biology, Cancer Biology,...PrincipalRegulatory$145.82k - $182.02k
...class targeted cancer therapies. We are advancing an innovative... ...team. The Senior / Principal Clinical Scientist,... ...clinical operations, regulatory affairs, and research... ...execution. Serve as Lead Clinical Scientist for... ...study reports, regulatory submissions, and publications....PrincipalRegulatory$146k - $188k
...class targeted cancer therapies. We are advancing an innovative... ...and motivated Senior/Principal Scientist in ADC... ...technology transfer, regulatory compliance, and... ...BLA-stage activities. Lead the multi-gram scale purification... ..., and regulatory submissions for clinical development...PrincipalRegulatory$150k - $185k
Using living cells to treat - and sometimes... ...with cell therapies. However, these... .... The Principal, Quality Assurance... ...Development, and Regulatory to support process... ...regulatory submission support for submission... ...readiness. Lead cross-... ...capability to oversee QA operations and...PrincipalRegulatoryWork at officeLocal areaShift work- ...the Bothell, WA site. The role focuses on final drug product and raw material release to market under cGMP, reporting to the Senior QA Manager. Responsibilities include COA management, EM data approval, lot genealogy review, and SOP development. Ideal candidates have...Suggested
$180k - $200k
...class targeted cancer therapies. We are advancing an innovative... ...and motivated Principal Purification Process... ...technology transfer, regulatory compliance, and coordination... ..., and regulatory submissions for clinical development... ...submissions. Lead/support authoring and...PrincipalRegulatory- Bristol Myers Squibb is seeking a Sr. Manager - QA Ops, Investigations in Bothell, WA to lead a team overseeing deviation management and CAPA workflows in cell therapy manufacturing. You will ensure regulatory compliance and drive continuous improvement across site QA operations...Regulatory
$226k - $270k
Immunome, Inc. is seeking a Global Regulatory Lead in Bothell, Washington, to drive the regulatory strategy for its oncology therapies. The role involves leadership of the Global... ...affairs. A history of successful regulatory submissions and a focus on oncology is strongly...Regulatory- ...Washington state is seeking a Senior / Principal Clinical Scientist, Clinical Development to lead design, execution, and... ...collaborates with clinical operations, regulatory affairs, and R&D to advance... ...study reports and regulatory submissions. The candidate should have...PrincipalRegulatory
- ..., Quality Operations (Investigations) to lead a team responsible for deviation management and CAPA workflows in Cell Therapy manufacturing. You will assure regulatory compliance and drive RCA-based problem solving across the QA Ops function. The role requires a Bachelor...Regulatory
$212.15k - $240k
...class targeted cancer therapies. We are advancing an innovative... .... This role will lead day-to-day activities... ...to align with regulatory updates and business needs... ...documentation related to QA operations. Regulatory... ...to support regulatory submissions, including providing...Regulatory$226k - $270k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...targets.Position OverviewAs the Global Regulatory Lead at Immunome, you will be the key decision... ...compliance with local regulations for global submissions.Stakeholder CommunicationCommunicate...RegulatoryLocal areaFlexible hours$177.81k - $203.99k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...Director, Quality Control, Biologics to lead QC strategy and execution in support of... ...documentation supporting clinical development and regulatory submissions. The successful candidate will bring...RegulatoryContract work$155k - $172k
...Principal Process Engineer – Global MSATAt Just Evotec Biologics,... ...assist in generation of relevant regulatory submissions, and provide support for... ...engineers.What You'll Do:Project Lead for technology transfer of a... ...a subject matter expert in cell culture biopharmaceutical...PrincipalRegulatoryTemporary workWorldwideFlexible hours$134k - $154.1k
...Principal Process EngineerLocation: Redmond, WAReports to: Director... ...Engineering team will lead the team responsible for the... ...assist in generation of relevant regulatory submissions, provide support for regulatory... ...Matter Expert) knowledge in cell culture biopharmaceutical...PrincipalRegulatoryTemporary workWorldwideFlexible hours$177.4k - $238.96k
...best-in-class targeted cancer therapies. We are advancing an... ...Associate Director / Director, Regulatory Affairs CMC, responsible for... ...adherence to accelerated regulatory submission schedules. Reporting into the... ...Serve as the regulatory CMC lead on cross-functional teams, providing...RegulatoryFlexible hours$287.89k - $394.94k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Writing... ...Support preparation of regulatory submissions and health authority interactions. Contribute...Regulatory$288.03k - $353.64k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...strategic Senior Director, Pharmacometrics to lead model-informed drug development... ...decisions, dose selection and optimization, regulatory submissions, and product labeling. The successful...Regulatory$260k - $353.6k
...-class targeted cancer therapies. We are advancing an innovative... ...Quality Assurance to lead and implement global... ..., data management, regulatory affairs, and external vendors... ...through regulatory submission, launch readiness, and... ...a risk-based Clinical QA strategy across GCP, GLP...RegulatoryLocal area- Immunome, Inc. in Bothell, Washington, seeks a Senior / Principal Clinical Scientist in Clinical Development to lead design, execution, and interpretation of oncology... .... You will collaborate with clinical operations, regulatory affairs, and R&D to advance multiple candidates....PrincipalRegulatory
$108.65k - $131.66k
...optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the... ...access our complete Equal Employment Opportunity statement. Regulatory Disclosure for California Residents If you live in or expect...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$94k - $129.25k
...enabling life-changing therapies for patients... ...Project Manager to lead biologics programs... ...expectations and regulatory requirements. About... ..., Analytical, QC, QA, MSAT, Supply... ...readiness, regulatory submissions, and... ...genetically engineered cells therapies. Across...RegulatoryFull timeContract work- ...in Bothell, WA is seeking a Sr. Manager - QA Ops, Investigations to lead deviation management and CAPA oversight for cell therapy manufacturing. You will drive quality initiatives... ...a cross-functional team, and ensure regulatory compliance across QA Operations. The role...Regulatory
- SLR Consulting is seeking a Principal Consultant to help expand its oil and gas industry business in the Gulf Coast Region. The ideal... ...possess extensive experience in environmental management and regulatory compliance, driving client satisfaction and business development...PrincipalRegulatoryFull time
$222.93k - $310.5k
...Director / Senior Director, Regulatory Affairs Advertising and Promotion... ...-in-class targeted cancer therapies. We are advancing an innovative... ...Serve as the regulatory lead for Immunome's Medical-Legal-... ...agency partners. Regulatory Submissions and Agency Interactions Oversee...RegulatoryRemote work$96k - $120k
Lyell Immunopharma, Inc. is seeking a Quality Assurance Specialist to oversee compliance in a cell therapy manufacturing environment. The role involves providing QA oversight for Facility, Equipment, Utility, and Computer System programs, ensuring adherence to GMP requirements...- Bristol Myers Squibb is seeking candidates to support routine Cell Therapy Manufacturing operations. You will learn and execute aseptic processing in a cleanroom, perform tasks per SOPs, and ensure safety, quality, and GMP compliance while working in a collaborative, fast...Work at office
$221.2k - $387.1k
...security from blocker to enabler.Role As Principal Engineer for AI Security Governance, you... ...individual-contributor role: you will lead through technical authority, architecture... ...solutionsWorking knowledge of compliance and regulatory standards, and experience in Agile...PrincipalRegulatoryPermanent employmentWork at officeImmediate startRemote workFlexible hoursShift work$123k - $170k
...values drive our collective progress and impact.The Principal Mechanical Engineer is responsible for leading the mechanical design of complex mechanical... ...other departments to ensure projects conform to all regulatory and quality requirements• Create part and assembly...PrincipalRegulatoryTemporary workWorldwideFlexible hours$138.31k - $169.89k
...class and best‑in‑class targeted cancer therapies. We are advancing an innovative... ...safety reporting in alignment with global regulatory requirements and Immunome’s internal standards... ...up, MedDRA coding, and regulatory submissions. Ensure cases are processed within required...Regulatory
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