Senior QA Director: GMP & CMC for Clinical Programs
Nurix
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, change control, and regulatory support for INDs/NDAs, partnering with Regulatory Affairs and contributing to eQMS improvements. Travel to CDMO sites is expected. #J-18808-Ljbffr Nurix
- ...Biosciences Inc. is seeking a Director of Good Manufacturing... ...Assurance to lead GMP QA oversight across drug products and biologics programs from toxicology through... ...week. Reporting to the Senior Director, GMP & GPA, you... ...collaborate across CMC, Regulatory Affairs, IT...Suggested
$280k - $300k
...seriously.POSITION SUMMARYThe Director, GMP Quality Assurance is... ...and commercial programs.The role manages multiple... ...compliance, and continuity of clinical and commercial supply.... ...QA oversight of finished product... ...commercialization.Strong knowledge of CMC development, process...SeniorContract workLocal area- ...Cytokinetics is seeking a Senior Manager, CMC Analytical, to lead analytical development and quality... ...for late-stage and commercial programs. You will oversee CROs/CDMOs, ensure data... ...and support regulatory submissions in a GMP environment. The role requires strong...Senior
- ...leadership across Cardiovascular & Metabolic and Infectious Diseases/Vaccines programs. You will design, execute, and communicate translational biomarker strategies spanning early to late clinical development. The role emphasizes decision-centric biomarker plans that...Senior
- ...an experienced, hands-on Sr. Director / Vice President, Manufacturing and CMC. In this high-impact executive... ...and bispecific antibody programs. We are at a pre-clinical stage and looking to advance... ...transfer, scale-up, and non-GMP/GMP manufacturing of Drug Substance...Senior
- Innova Solutions is seeking a Senior Manager, CMC QC for our Brisbane, CA hybrid program. The role supports review of release... ...successful candidate will bring GMP/ICH knowledge, analytical/biological... ...-week contract role to support clinical-to-commercial milestones. #J-1880...SeniorContract workPart time
$235.5k - $329.5k
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company... ...-stage portfolio includes programs for chronic hepatitis delta and... ...is seeking an experienced Senior Director, Clinical Research Oncology Program... ..., Biometrics, Safety, CMC/Technical Operations, Medical...SeniorFull timeWork at officeWork visa3 days per week- ...Vir Biotechnology seeks a Senior Director, Clinical Research Oncology Program Executive to shape development and strategic planning of oncology programs. You will lead cross-functional teams, align stakeholders, and drive integrated development plans across translational...Senior
$164k - $205k
...A late-stage clinical oncology company is seeking a Sr. Clinical Program Manager to serve as a central contact for clinical study teams. Responsibilities include managing trial aspects, overseeing budgets, and collaborating with cross-functional teams. Candidates must...Senior$190k - $240k
Join to apply for the Director of Clinical Quality Assurance role... ...Alumis. The Clinical QA Director is responsible... ...the ongoing clinical programs through oversight, assessment... ...along the way. Seniority level Seniority level... ...ago Associate Director, GMP Quality Assurance...Full time- ...employment. Position: Director/Senior Director of Quality... ...Neurona Therapeutics is a clinical stage biotechnology... ...our Quality Assurance (QA) team. Our ideal candidate... ...Practices (GMP and ISO), safety policies... ...engineering and manufacturing programs, standards and...SeniorWorldwide
- ...for employment. Position: Senior Manager/Associate Director, CMC Project Management Location... ...teams supporting clinical supply, late-stage development... ...Quality stakeholders. Support program budgeting, forecasting, resource... ...of CMC development, GMP manufacturing, technical operations...SeniorFull time
$70 - $74 per hour
...Position Senior Manager, CMC QC Position type: Part-time- Contract Duration... ...Manager/Senior Manager for our clinical and commercial programs in the CMC Quality Control... ...organization activities to fulfill the GMP QC testing needs. Work within QC, with QA, and other departments to...SeniorHourly payContract workTemporary workPart timeWork experience placementInterim roleWorldwideFlexible hours1 day per week$273k - $290k
...oligos. With multiple programs in metabolic... ...advancing toward the clinic, and our first IND... ...are looking for a Senior Director of Quality... ...insitro's approach to GMP and GCP quality, clinical... ..., regulatory, CMC, and data science... ...progression into senior QA leadership.Small-...SeniorHome officeFlexible hours3 days per week$150k - $170k
...South San Francisco, is a clinical-stage biotechnology... ...for a talented, motivated Senior Manager to join our Portfolio & Program Management Team. This individual... ...with an emphasis on CMC knowledge and the ability... ...Office Suite) Knowledge of GMP/GxP-regulated...SeniorWork at officeLocal areaRemote work$187.8k - $208.6k
...Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)Shape the CMC regulatory path for Nurix's small molecule portfolio, from clinical development through marketed lifecycle. You'll combine... ...strategies for assigned programs (drug substance and drug...SeniorLocal area- Role: Senior Director, Program Management leading cross-functional drug development programs from strategy to execution. Responsibilities... ...program timelines, align functional plans across clinical, regulatory, CMC, nonclinical, and commercial teams; manage risks, trade...Senior
$280.2k - $319.8k
...Senior Director Quality Control Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery development... ...systems and a team to support programs from CMC development through commercial... ...life supply continuity or GMP compliance; drive risk...SeniorFull timeFor contractors$270k - $325k
POSITION SUMMARY: The Senior Director, Program Management is a senior cross-functional leader responsible for helping move complex drug... ...from strategy to execution.This role works across clinical, regulatory, CMC, nonclinical, commercial and other functions to connect...SeniorRemote workFlexible hours$150k - $160k
Olema Oncology is a clinical-stage biopharmaceutical company... ...data from this program across multiple solid tumor... .... About the Role >>> Senior Manager, Clinical Supply... ...with Clinical Operations, CMC, Quality, Regulatory,... ...Working knowledge of GMP, GDP, Quality, Clinical...SeniorWork at officeFlexible hours$250k - $311k
...Executive Director, Clinical OperationsXaira Therapeutics is seeking an Executive... ...function as its first programs move from IND into the clinic... ...and data organization, and senior leadership. The Executive Director... ...and Data Management, CMC and clinical supply, Finance...SeniorFlexible hours- ...mentor the Oligonucleotide & Small Molecule CMC Analytical Development team, providing... ...activities for oligonucleotide and small-molecule programs, develop and validate analytical methods,... ..., analytical development supporting clinical phases, regulatory documentation, GxP...
- ...AbbVie in South San Francisco seeks a physician leader to oversee direction, planning, execution, and interpretation of clinical development programs. You will participate in cross-functional teams to deliver high-quality clinical data aligning with product strategy. Role...Senior
$159k - $207k
...specifically designed to cross the BBB, a clinically validated delivery platform and a growing... ...the Oligonucleotide & Small Molecule CMC Analytical Development team while providing... ...technical challenges and advance development programs. Key Accountabilities / Core Job...Local area- ...Structure Therapeutics Inc. is seeking a Senior Medical Director to provide medical support on clinical drug development for the assigned compound(s). You will... ...will lead medical monitoring oversight across programs, assist in study design, participate in regulatory...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
- ...Septerna, a South San Francisco biotechnology company, seeks a Senior Medical Director, Clinical Development to provide strategic leadership for all clinical development activities and to lead a key clinical program. You will design the clinical development plan, interact...Senior
- ...Health & Hospice, based in San Francisco, seeks a DPCS to own clinical performance across Bay Area branches. You will set agency-wide... .../Administrator and requires CA RN licensure, BLS/CPR, and a track record of leading multi-site home health programs. #J-18808-Ljbffr...SeniorFull timeWork from home
- ...AbbVie seeks a Senior Medical Director for Oncology Clinical Development (GI) to lead the design, execution, and interpretation of complex clinical programs across global sites. The role requires strong medical leadership, regulatory understanding, and collaboration with...Senior
- ...Nurix Therapeutics seeks an experienced clinical development leader to drive oncology programs. Reporting to the Chief Medical Officer, the role guides strategy, protocols, and regulatory support across US and international sites, with safety oversight alongside the Medical...Senior
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