VP, Regulatory Affairs & Quality (GxP) - Oncology Leader
Jobleads-US
Pliant seeks a Vice President, Regulatory Affairs & Quality (GxP) to lead global regulatory and quality across oncology programs, including an early phase lead candidate. This hands-on leader will design scalable GxP infrastructure in clinical, manufacturing and lab settings while ensuring rapid, compliant execution.
The role interfaces with FDA and other health authorities, guides pathways and designations, and manages a lean Quality team within a Phase 1/2 organization, with 15-20% travel.
#J-18808-Ljbffr Jobleads-US- Pliant Therapeutics, Inc. is seeking a Vice President of Regulatory Affairs & Quality (GxP) to lead and scale our global regulatory and quality... ...years in regulatory/quality within biotech, with direct oncology experience and a track record of IND/CTA submissions, FDA...Quality
- ...Vice President, Regulatory Affairs & Quality (GxP) About the Company Clinical-stage biopharmaceutical... ...fibrosis integrins muscle biology oncology duchenne muscular dystrophy... ...compliance with all relevant regulations. The VP will also be involved in strategic...Quality
$351k - $388k
...Operating Officer, the Vice President, Regulatory Affairs & Quality (GxP) will lead and oversee an integrated Regulatory... ...of programs, including our lead oncology program currently in Phase 1b. This is a hands‑on role for a leader who will own day‑to‑day global...QualityFull time3 days per week$351k - $388k
Vice President, Regulatory Affairs & Quality (GxP) At Pliant, we believe differentiated science can make a meaningful... ...of programs, including our lead oncology program currently in Phase 1b. This is a hands‑on role for a leader who will own day-to‑day global regulatory...QualityFull timeContract workFor contractorsFor subcontractorWork at office3 days per week- ...Therapeutics is seeking an Associate Director, Computer Systems Assurance (CSA) in Brisbane, CA to lead the GxP CSA program across Quality Systems, IT, Regulatory Affairs, and Clinical Operations. The role focuses on risk-based validation of SaaS and cloud-hosted platforms...Quality
- Olema Oncology seeks an experienced Global Regulatory Affairs Compliance Associate Director to advance regulatory strategies across our development programs.... ...with laws, regulations, and guidance, and manage high-quality submissions (INDs, NDAs, health authority materials...Quality2 days per week
- ...biopharmaceutical company advancing therapies for HCM. The Associate Director, Quality Systems will lead the QMS, ensure GxP document control, and drive training and compliance across departments. Reporting to the VP of Quality, this role will help prepare for inspections, manage...Quality
- ...Therapeutics is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the medical... ...writers, ensure timely and high-quality deliverables, and collaborate with Clinical Science and Regulatory teams across oncology programs. The role requires extensive experience...QualityContract work
- ...Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate with regulatory, quality, clinical, and manufacturing teams to develop regulatory strategies...Quality
- Director, Safety Statistics Group Oncology TA Head Join to apply for the Director, Safety... ...Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians... ...Oversight to ensure the delivery of high-quality outputs according to agreed-upon...QualityFull timeTemporary workWork at office
- insitro is seeking a Senior Director of Quality Assurance to build a pragmatic, inspection-ready quality function for clinical-stage operations. You will own GMP/GCP quality, data integrity, and vendor quality at the intersection of outsourced development and AI-enabled...Quality
$369k
...transformative medicines for oncology, autoimmune... ...Primary Function: The VP, Global Medical Affairs will build and lead... ...outside China. This leader will establish the... .... Partner with Regulatory Affairs on US label... ...programs, ensuring high-quality, timely...QualityWork at officeWorldwideRelocation package$142k - $213k
...and precise. Description The Quality Systems and Compliance Lead drives... ...of quality, reliability, and regulatory compliance. Responsibilities... ...to the QMS through ongoing GxP training, education, and... ...quality assurance or regulatory affairs within the medical device, digital...QualityFull time$315k - $340k
...Vice President, Quality AssuranceOlema Oncology is a clinical-stage biopharmaceutical... ...Assurance serves as the senior leader accountable for defining... ...integrityPartner with Clinical and Regulatory to support inspection-ready... ...FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV)...QualityWork at officeFlexible hours- ...New York, SF, Chicago, Charlotte, or Boston. The role requires leading transactions, mentoring junior bankers, and delivering high-quality client materials. Candidates should have 5+ years in investment banking (MBA with 3+ years accepted), strong M&A experience, and solid...Quality
$146.25k - $243.75k
Job title: Thought Leader Liaison Hematologic Oncology - Pacific CoastLocation: US / Remote... ...in Marketing, Medical Affairs, Sales, and Market Access... ...compliance, legal and regulatory guidelines.KOL Engagement... ...benefits including high-quality healthcare, prevention and...QualityFull timeContract workWork experience placementWork at officeLocal areaRemote workHome office$330k - $375k
...patients. The Vice President, Specialty Oncology is the end-to-end business owner for the... ...revenue, pipeline and market shaping. This leader owns the commercial and medical education... ...and MRD monitoring Partner with Medical Affairs to drive guideline inclusion and publication...Full timeWorldwide$211k - $264k
...Revolution Medicines is a late-stage clinical oncology company developing novel targeted... .... The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for... ...Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial....QualityFull timeWork experience placementLocal area$244k - $305k
...a late-stage clinical oncology company developing novel... ..., Molecule Global Regulatory Lead will develop and... ...lifecycle management. This leader will shape innovative... ...CMC to deliver high-quality global submissions. Cross... ...+ years of regulatory affairs experience within the...QualityFull timeLocal area$360k - $425k
...including Clinical Operations, Regulatory Affairs, Translational Science, Safety, Quality and others in supporting our efforts... ...are not limited to: Lead the Oncology Clinical Development team,... ...advisory boards Key member and/or leader of the oncology asset teams in...QualityFull timeInternshipWork at officeLocal areaRemote work- Job Summary: The VP, Quality & Regulatory Affairs is an executive leadership role responsible for defining and executing the strategic direction for... ...the Quality and Regulatory functions. This executive leader provides strategic and operational oversight of Quality Assurance...Quality
- Rigel Pharmaceuticals Inc is seeking a Senior Manager Quality Assurance Quality Operations to oversee GMP QA activities for commercial and clinical products manufactured and tested globally. You will ensure manufacturing readiness, batch disposition, change management and...Quality
- A leading life sciences company in South San Francisco is seeking a Director of Clinical Quality Assurance to ensure compliance with FDA regulations and oversee GCP QA programs. The ideal candidate will have extensive experience in clinical quality assurance and expertise...Quality
- ...close-out in compliance with ICH-GCP and local regulations. You will coordinate cross-functional teams across timelines, budgets, and quality requirements to ensure successful trial delivery. This role is based in South San Francisco, CA. Responsibilities include vendor...QualityLocal area
- ...Therapeutics is seeking a Senior Director of Quality Systems and Compliance to craft and... ...with up to two remote days weekly, this leader will mature QMS, drive inspection readiness, and partner with Manufacturing, Regulatory, and Clinical QA to ensure patient safety...QualityRemote work
- ...Trevor Williams on coverage of information services, payroll software, and remittance companies, generating high‑quality research and client insights. The VP will mentor junior analysts, build advanced financial models, and collaborate across teams to shape FT Partners'...Quality
- ...Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology & Retina About the Company Well-funded clinical-stage biotech in ophthalmology... ...About the Role The Company is in search of a VP of Regulatory Affairs to take on a founding role in building...
$306k
...is a senior scientific leader responsible for integrating... ...clinical development, regulatory submission, and life-... ...Science, Regulatory Affairs, Pharmacovigilance, CMC... ...collaborators; ensure scientific quality, timely execution,... ..., and appropriate GxP compliance.Build, lead,...QualityRemote workFlexible hours$300k - $390k
...activities. As a strategic and results-oriented senior leader within Technical Operations, this individual... ...for CDMO performance, including quality, timelines, cost, and compliance.Partner with Quality and Regulatory to ensure GMP compliance, inspection readiness...QualityContract workInterim role- ...• Leads or oversees a diverse range of initiatives to improve quality, compliance, cost or speed of projects across AstraZeneca and,... ...of the drug development process, coupled with the appropriate regulatory and commercial insights ~ A deep and broad understanding of...QualityHourly payTemporary work
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