Quality Assurance Director / Sr. Director (GVP/PV)

BridgeBio
San Francisco
Workplace: HybridFull timeUSD 245,000 - 280,000 annuallyFunction: QA, Test & Release EngineeringExperience: 10-15 yearsEducation: bachelorsSkills: ["Analytical","Communication","Leadership","Cross-functional collaboration","Stakeholder management"]

Lead the GVP quality and compliance program for BridgeBio affiliates, advising on FDA/EMA/MHRA and ICH PV regulations; manage GVP regulatory inspection activities, audit programs, CAPAs, and regulatory responses; serve as a primary contact for PV quality data and inspection readiness, collaborating cross-functionally to uphold pharmacovigilance standards.

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BridgeBio
BridgeBio
4 months ago

Quality Assurance Director / Sr. Director (GVP/PV)

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Source: Company careers pageValidated by: Fursa AI
Last checked: 7 hours agoStatus: Live

Job Summary

Lead the GVP quality and compliance program for BridgeBio affiliates, advising on FDA/EMA/MHRA and ICH PV regulations; manage GVP regulatory inspection activities, audit programs, CAPAs, and regulatory responses; serve as a primary contact for PV quality data and inspection readiness, collaborating cross-functionally to uphold pharmacovigilance standards.
Location: San Francisco
Workplace: Hybrid
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Sr. Director level

Key Responsibilities

  • •Provide strategic and operational guidance to drug safety/pharmacovigilance, regulatory, medical affairs, clinical operations and outsourcing functions to align with procedures and regulatory requirements
  • •Support the internal and external GVP audit program, oversee audit schedule and execution
  • •Lead or co-lead PV audits as needed and review/update CAPA responses
  • •Maintain and contribute audit/quality data for the Pharmacovigilance System Master File (PSMF)
  • •Lead or participate in inspection readiness activities and host/regulatory inspections
  • •Review quality agreements and PV/SDEA agreements to ensure compliance and quality standards

Pay and Benefits

Salary: USD 245,000 - 280,000 annually
Equity and Bonus:Equity
Perks:Health Insurance401kEsppHsaFsaParental LeaveDentalVision

Key Requirements

  • •Bachelor's degree in a related field
  • •10-15+ years of GVP quality and compliance experience in biopharma or CRO
  • •Current knowledge of global GVP regulations and guidelines (US CFR, EMA, MHRA, ICH)
  • •Ability to engage in cross-functional interactions with internal and external staff
  • •Strong analytical and business communication skills
Experience:10-15 yearsBiopharmaceuticalPharmacovigilanceDrug safety
Education:Bachelor's in Biology
Skills:AnalyticalCommunicationLeadershipCross-functional collaborationStakeholder management
Languages:English

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn