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
$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$170k - $196.23k
...best-in-class targeted cancer therapies. We are advancing an... ...experienced and collaborative Principal Scientist, Analytical Development... ...analytical documents for regulatory submissions. ResponsibilitiesDevelop... ...and regulatory requirements. Lead investigations of method...PrincipalRegulatoryContract workAfternoon shift- 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
$169.59k - $206.23k
...best-in-class targeted cancer therapies. We are advancing an... ...are seeking an experienced Principal Scientist, Chemical Development... ...person will play a key role in leading challenging drug candidate process... ...sections of various regulatory documents (IND, IMPD, NDA, briefing...PrincipalRegulatoryAfternoon shift- ..., 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$149.93k - $203.96k
...developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics,... ...deliver high-quality data that informs decision-making and regulatory submissions. Reporting to the Executive Director, Head of ADME, the Scientist...Regulatory$259.08k - $396.2k
...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- ...Manager of Quality Operations (Investigations) to lead deviation and CAPA workflows in cell therapy manufacturing. This role supervises a team, drives continuous improvement, and partners across QA Ops to ensure regulatory excellence. The ideal candidate has 6+ years GxP...Regulatory
$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- 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
$94k - $129.25k
...enabling life-changing therapies for patients... ...Project Manager to lead biologics programs... ...expectations and regulatory requirements.You will... ..., Analytical, QC, QA, MSAT, Supply... ...readiness, regulatory submissions, and... ...genetically engineered cell therapies. Across...RegulatoryContract work$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$260.97k - $309.34k
...best-in-class targeted cancer therapies. We are advancing an... ...budget, and in compliance with regulatory requirements and corporate objectives... ...development programs and/or lead key projects.... ...decisions. Support regulatory submissions (INDs, NDAs, BLAs) and health...Regulatory- AGC Biologics, Inc. invites a Senior Director, Business Development (Cell & Gene Therapy) to lead strategic partnerships across plasmid DNA, cell therapy, and gene therapy programs. You will identify opportunities, engage with biotechs and pharma, and drive deals from...Full timeRemote work
- ...improving patients' lives. Our lead drug candidates, lasofoxifene... ...5, are novel, small molecule therapies with the potential to address... ...is seeking a Director, Regulatory Affairs, Strategy to lead global... ...module ownership, content plan, submission timeline — through submission...Regulatory
$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$270k - $290k
...amyotrophic lateral sclerosis (ALS). Our lead programs, lasofoxifene and brelgometon, are novel small-molecule therapies with the potential to address devastating... ...and analysis through data interpretation, regulatory submissions, and health authority interactions....RegulatoryTemporary workInterim roleImmediate startFlexible hours$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$155k - $215k
...Experience with mixed signal circuit board development utilizing embedded microprocessors and FPGAs is a plus.Demonstrated sound regulatory approaches to technical solutions for medical devices.A solid working knowledge EDA CAD tools and design for manufacturability and...PrincipalRegulatoryTemporary workWork at officeFlexible hours$130k - $160k
...SystImmune is a leading and well-funded clinical-stage biopharmaceutical... .... We are seeking a Principal Scientist to provide... ...from early feasibility through regulatory submission and commercialization... ...with Regulatory Affairs and QA to support CDx regulatory strategy...PrincipalRegulatoryFull time- ...Biologics in Redmond, WA seeks a motivated senior scientist to lead cell-based assay development for biotherapeutics across early and... ...on experience with diverse cell assay formats, mentoring direct reports, and authoring regulatory documentation. #J-18808-Ljbffr EvotecRegulatory
$222.29k - $294.01k
...best-in-class targeted cancer therapies. We are advancing an... ...alignment with corporate and regulatory objectives. Proactively identify... ...manage emerging safety signals, leading benefit-risk evaluations and... ...sections of regulatory submissions including INDs, NDAs, BLAs,...Regulatory$155k - $170k
...Work you will do as an ISOutsource Principal Consultant: Client retention, wallet... ...solution development, and implementation Lead client relationships and project teams for... ...infrastructure and productivity Communicate regulatory shortcomings and manage IT security...PrincipalRegulatoryLocal areaRelocationNight shift$92.29k - $111.84k
...production line to the latest breakthroughs in cell therapy, this is work that transforms the lives... ..., CAPAs, change controls, and other QA department needs as identified by... ...oversight of cGMP operations during audits and regulatory inspections. Work is performed in a...RegulatoryFull timeTemporary workWork experience placementWork at officeFlexible hoursShift work$200.85k - $227.32k
...best-in-class targeted cancer therapies. We are advancing an... ...project development plans, and regulatory issues.Provide strategic statistical... ...and quality of study- and submission-level statistical deliverables... ...resolve data issues.Develop and lead initiatives in process...Regulatory- ...to ensure timely release of finished drugs and raw materials per cGMP standards. This full-time role reports to the Senior Manager of QA - Lot Disposition. Responsibilities include disposition activities, reviewing COA, ensuring documentation is complete, supporting...Full time
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