Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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
Vacancy posted 7 hours ago
Similar jobs that could be interesting for youBased on the VP, Regulatory Affairs & Quality (GxP) - Oncology Leader in South San Francisco, CA vacancy
  • 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

    Pliant Therapeutics, Inc.

    South San Francisco, CA
    3 days ago
  •  ...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

    Confidential

    South San Francisco, CA
    2 days ago
  • $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... 
    Quality
    Full time
    3 days per week

    Menlo Ventures

    South San Francisco, CA
    14 hours ago
  • $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... 
    Quality
    Full time
    Contract work
    For contractors
    For subcontractor
    Work at office
    3 days per week

    Pliant Therapeutics, Inc.

    South San Francisco, CA
    3 days ago
  •  ...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

    Nurix Therapeutics

    Brisbane, CA
    3 days ago
  • 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... 
    Quality
    2 days per week

    Olema Oncology

    San Francisco, CA
    3 days ago
  •  ...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

    Brave

    San Francisco, CA
    4 days ago
  •  ...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... 
    Quality
    Contract work

    BioSpace

    Brisbane, CA
    3 days ago
  •  ...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

    ORIC Pharmaceuticals Inc.

    South San Francisco, CA
    4 days ago
  • 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... 
    Quality
    Full time
    Temporary work
    Work at office

    BioSpace

    South San Francisco, CA
    4 days ago
  • 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

    insitro

    South San Francisco, CA
    1 day ago
  • $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... 
    Quality
    Work at office
    Worldwide
    Relocation package

    Zai Lab (US) LLC

    South San Francisco, CA
    2 days ago
  • $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... 
    Quality
    Full time

    Verily Health

    San Bruno, CA
    1 day ago
  • $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)... 
    Quality
    Work at office
    Flexible hours

    Olema Oncology

    San Francisco, CA
    2 days ago
  •  ...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

    Piper Sandler

    San Francisco, CA
    1 day ago
  • $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... 
    Quality
    Full time
    Contract work
    Work experience placement
    Work at office
    Local area
    Remote work
    Home office

    Sanofi

    San Francisco, CA
    4 days ago
  • $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 time
    Worldwide

    CareDx, Inc.

    Brisbane, CA
    16 hours ago
  • $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.... 
    Quality
    Full time
    Work experience placement
    Local area

    Revolution Medicines

    San Francisco, CA
    1 day ago
  • $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... 
    Quality
    Full time
    Local area

    Revolution Medicines

    San Francisco, CA
    6 hours ago
  • $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... 
    Quality
    Full time
    Internship
    Work at office
    Local area
    Remote work

    Allogene Therapeutics

    South San Francisco, CA
    more than 2 months ago
  • 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

    Gateway Recruiting

    San Francisco, CA
    3 days ago
  • 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

    Rigel Pharmaceutical, Inc.

    South San Francisco, CA
    3 days ago
  • 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

    BioSpace

    South San Francisco, CA
    4 days ago
  •  ...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... 
    Quality
    Local area

    Zai Lab (US) LLC

    South San Francisco, CA
    2 days ago
  •  ...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... 
    Quality
    Remote work

    Allogene Therapeutics

    South San Francisco, CA
    3 days ago
  •  ...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

    FTP PARTNERS

    San Francisco, CA
    4 days ago
  •  ...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... 

    Confidential

    San Francisco, CA
    16 hours ago
  • $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,... 
    Quality
    Remote work
    Flexible hours

    Rigel Pharmaceuticals

    South San Francisco, CA
    1 day ago
  • $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... 
    Quality
    Contract work
    Interim role

    Structure Therapeutics

    South San Francisco, CA
    1 day ago
  •  ...• 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... 
    Quality
    Hourly pay
    Temporary work
    South San Francisco, CA
    9 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to VP, Regulatory Affairs & Quality (GxP) - Oncology Leader. Be the first to apply!