Senior Director, GMP Quality Assurance | Late-Stage
Regulatory Jobs
Nurix Therapeutics is seeking a Director of Quality Assurance to lead GMP QA for small molecule CMC programs and serve as the primary interface with CDMOs. You will be accountable for the quality and timely supply of clinical materials, and for inspection readiness while building and mentoring the QA team as we advance toward commercialization. Reporting to the Senior Vice President of Quality, you will provide strategic leadership across QA, CMC, and Regulatory Affairs, ensuring FDA/ICH/GMP #J-18808-Ljbffr Regulatory Jobs
$280k - $300k
...have fun, seriously.POSITION SUMMARYThe Senior Director, GMP Quality is responsible for the global oversight and management of GMP Quality Assurance operations supporting development and... ...product development from early-stage development through global commercialization...SeniorContract workLocal area- Cytokinetics is seeking a Senior Manager, CMC Analytical, to lead analytical development and quality control activities for late-stage and commercial programs. You will oversee CROs/CDMOs... ...and support regulatory submissions in a GMP environment. The role requires strong...Senior
$219k - $267k
...Director, Gmp QualityAt Maze, we're translating human... ...an important stage in building the capabilities... ...needed to support late-stage development... ....As Director, GMP Quality, you'll play a key... ...Senior Management decisions... ...pharma GMP quality assurance, with direct experience...Suggested3 days per week- ...IDEAYA Biosciences Inc. is seeking a Director of Good Manufacturing Processes, Quality Assurance to lead GMP QA oversight across drug products and biologics programs... ...San Francisco four days a week. Reporting to the Senior Director, GMP & GPA, you will collaborate...Suggested
- ...Incorporated in South San Francisco, CA, seeks a Senior Manager, CMC Analytical, to lead analytical development and quality control activities for late-stage programs and commercial manufacturing.... ...external partners. This role requires GMP expertise, CRO/CDMO oversight, data...Senior
$273k - $290k
...are at a pivotal inflection point.We are looking for a Senior Director of Quality Assurance to build a pragmatic, inspection-ready quality function for clinical-stage operations. You will own insitro's approach to GMP and GCP quality, clinical data quality oversight, and...SeniorHome officeFlexible hours3 days per week$229k - $297k
...and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of... ...Job Responsibilities: Oversee both clinical and commercial GMP and GLP quality operations at CMOs, including quality documentation reviews...SeniorLocal area- ...employment. Position Director/Senior Director of Quality Operations Location... ...Therapeutics is a clinical stage biotechnology company based... ...candidate to join our Quality Assurance (QA) team. Our ideal... ...Neurona. This role ensures GMP compliance across day-to-day...Senior
- Nurix Therapeutics in Brisbane, CA is seeking a Lead GMP Quality Assurance leader for small molecule CMC programs. You will be the primary QA interface with CDMOs, ensure GMP compliance, and maintain inspection readiness while mentoring the QA team. You will drive CAPA,...Senior
- ...Nurix Therapeutics is seeking a Lead GMP Quality Assurance professional to direct QA for our small molecule CMC programs and to serve as the... ...readiness while building and mentoring the QA team as we advance late-stage development toward commercialization. You will provide...Contract work
- Biogen is seeking a Senior Principal Biostatistician, West Coast Hub, to lead statistical support for late-stage nephrology programs and early indications. You will shape study design, analyze data, and author analysis plans and reports, mentoring junior statisticians...Senior
- ...Denali Therapeutics Inc. is advancing a portfolio of biotherapeutics designed to cross the blood-brain barrier. The role oversees GMP and GLP quality operations at CMOs, ensuring batch release disposition and product quality across clinical and commercial products. The...Senior
- ...Structure Therapeutics is seeking a Director of Technical (CMC) Project Management to lead late‑stage CMC programs from development through commercialization. You will drive integrated plans, budgets, risk management and cross‑functional alignment with Tech Ops and CDMOs...Senior
$260k - $275k
...Vaxart is a clinical-stage biotechnology company developing a... ...We are looking for a Sr. Director, Quality Assurance (QA) to join our South San Francisco... ...Office. Summary The Senior Director, Quality Assurance... ...programs and related GMP manufacturing, testing, and...SeniorContract workFor contractorsWork at officeShift work$228.1k - $252k
...Lead GMP quality assurance for Nurix's small molecule CMC programs and serve as the primary quality... ...the QA team as we advance through late-stage development toward commercialization.... ...Description The Opportunity Report to the Senior Vice President, Quality, in a high-...Contract workLocal area$243.1k - $314.6k
...Gilead and help create possible, together.Job DescriptionSr. Director, ERP GMP Quality LeadRole OverviewThe ERP GMP Quality Lead provides quality... ...appropriate, and supported by proportionate risk-based assurance across sites, functions, regions, and integrated systems....SeniorFull timeFor contractorsLocal area$181.62k - $211.89k
...Analytical Chemist with expertise in late-stage analytical development and... ...in Analytical Development, Quality Control, and technical support... ...team environment.Job PurposeThe Senior Manager, CMC Analytical, is... ...quality control activities in a GMP environment....SeniorContract workWork experience placement- ...in South San Francisco, is a clinical-stage biotechnology company pioneering the... ...commercial milestones, we are seeking a Senior Director of Quality Systems and Compliance to shape and... ..., Regulatory, and Clinical Quality Assurance to foster a culture of quality and compliance...SeniorWork at officeLocal areaRemote work2 days per week
$200k - $247k
...We are seeking a Director of Good Manufacturing Processes, Quality Assurance to join our IDEAYA... ...team. The Director, GMP, Quality Assurance... ...Reporting to Senior Director, GMP & GPA... ...used in early and late-phase studies.... ...support for development-stage manufacturing,...Contract workTemporary workWork at officeLocal areaWork from home- ...applicants for employment. Position: Director/Senior Director of Quality Assurance - Medical Device Location: South... ...Neurona Therapeutics is a clinical stage biotechnology company based in... ...with Good Manufacturing Practices (GMP and ISO), safety policies, and good...SeniorWorldwide
- ...Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted... .... You will collaborate with cross-functional teams to implement quality systems, monitor data integrity, and drive continuous...Senior
$158.7k - $172.1k
...Summary Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the... ...Investigations, CAPA, Change Control, Complaints, Quality Metrics, and other core QMS programs. Led... ...4+ years in Quality Systems / Quality Assurance. Strong working knowledge of quality...SeniorWork at office$164k - $205k
...corrective actions. Maintain the internal/external audit schedules. Assure GMP/GxP compliance with suppliers. Oversight of all aspects of GxP... ...with vendors and internal teams to draft and complete Quality Agreements. Perform Risk Assessments, qualifications, and monitor...SeniorWork at officeImmediate startWorldwideFlexible hours- Osanni Bio in San Francisco Bay Area is seeking an Associate Director, Quality Systems to establish and lead the hub quality management system across GLP, GCP, and GMP programs. You will own document control, training, deviations, CAPA, change control, and supplier quality...Senior
- ...Inc. in the South San Francisco and Redwood Shores area is seeking an experienced Senior QA Manager to lead investigations, CAPA, change control, supplier quality, and MRB activities in a GMP cell therapy setting. You will be the on-site QA presence at CDMOs and...Senior
- Cytovale, Inc. in South San Francisco, CA is seeking a Head of Quality and Regulatory to own the QMS and serve as the Management Representative. This senior leadership role partners with Regulatory and Operations to drive compliant design, manufacturing, and post-market...Senior
- ...Denali Therapeutics Inc. is seeking a senior leader to safeguard the clinical development portfolio's quality by directing enterprise GCP/GCLP quality strategy. You will lead the Clinical Quality organization, manage audit programs across CROs and sites, and ensure...Senior
- Neurona Therapeutics, a clinical stage biotechnology company in South San Francisco, seeks a Director/Senior Director of Quality Assurance - Medical Device. The role leads QA activities for the device portion of a combination product, shaping quality systems and compliance...Senior
- ...Maze Therapeutics is seeking a Director of GMP Quality to lead quality oversight across development programs and external manufacturing partners. You will drive phase-appropriate quality decisions, readiness for inspections, and continuous improvement of quality systems...
- ...Delta Dental Ins. is seeking a Senior Director of Clinical Quality & Policy in San Francisco, California. This role involves providing clinical leadership for a transforming dental health plan, ensuring evidence-based care and management of quality strategies. The ideal...Senior
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