Quality Assurance Director / Sr. Director (gvp/pv)

BridgeBio

San Francisco, United States
Base: $245,000—$280,000 usd; bonus/equity: annual ...
On-site
Good pharmacovigilance practices (gvp)
Gvp regulatory inspection activities
Gvp quality and compliance program
Responsible for managing and overseeing the Good Pharmacovigilance Practices (GVP) quality and compliance program at Eidos Therapeutics and other assigned BridgeBio affiliate companies

Job Summary

  • Responsible for managing and overseeing the Good Pharmacovigilance Practices (GVP) quality and compliance program at Eidos Therapeutics and other assigned BridgeBio affiliate companies.
  • Lead or co-lead auditor on PV audits as needed, and host or support of regulatory inspections.
  • Develop, generate and present PV quality/compliance metrics for trending and process improvement.

Matching Summary

Responsible for managing and overseeing the Good Pharmacovigilance Practices (GVP) quality and compliance program at Eidos Therapeutics and other assigned BridgeBio affiliate companies.

Salary

Base: $245,000—$280,000 USD; Bonus/Equity: annual performance bonus, company equity; Benefits: generous health benefits

Skills & Requirements

Must-have

  • Good Pharmacovigilance Practices (GVP)
  • GVP regulatory inspection activities
  • GVP quality and compliance program
  • global GVP regulations and guidelines
  • PV audits and CAPA responses

Nice-to-have

  • defies convention
  • curiosity and experimentation
  • ethical & thoughtful use of AI
  • moneyball for biotech approach

Key Requirements

  • 10-15+ years of GVP quality and compliance experience
  • Bachelor's degree
  • Current knowledge of global GVP regulations
  • Ability to engage in cross-functional interactions

Work Rights

Not specified

Tailored Resume

Cover Letter