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

BridgeBio Pharma•San Francisco, CA

10d•Hybrid

About The Position

The Director / Senior Director, Quality Assurance is responsible for managing and overseeing the Good Pharmacovigilance Practices (GVP) quality and compliance program at Eidos Therapeutics and other assigned BridgeBio affiliate companies. It requires strong judgement skills and business acumen in order to advise internal and external key stakeholders on interpretation and compliance with FDA, EMA, MHRA and international pharmacovigilance (PV) regulations/guidelines; corporate policies; and standard operating procedures (SOPs). This individual will be a lead point of contact in the preparation and management of GVP regulatory inspection activities.

Requirements

Bachelor’s degree with 10-15+ years of GVP quality and compliance experience within a biopharmaceutical company, or contract research organization
Current knowledge of global GVP regulations and guidelines – US Code of Federal Regulations, EMA, MHRA, and ICH Guidelines
Ability to engage in cross-functional interactions with internal and external staff
Has a comprehensive understanding of current approaches in industry and the ability to incorporate them into Eidos and BridgeBio affiliate programs
Applies strong analytical and business communication skills

Responsibilities

Provide strategic and operational guidance to the organization, including, drug safety/pharmacovigilance, medical affairs, regulatory, commercial, clinical operations and outsourcing functions, to align with company procedures, regulatory requirements and best practice
Support the internal and external GVP audit program
Oversee audit schedule and the execution of the audit program
Lead or co-lead auditor on PV audits as needed
Review and/or approval of audit reports and corrective and preventive action (CAPA) responses
Maintain and contribute of audit and quality data for the Pharmacovigilance System Master File (PSMF)
Core GVP regulatory inspection team member
Lead or participate in inspection readiness activities
Host or support of regulatory inspections
Perform quality review of inspection requests
Oversee the development and tracking of regulatory responses/commitments
Review of Quality Agreements and PV/Safety Data Exchange Agreements (PVA/SDEA) to assess quality standards and regulatory compliance requirements
Participate in the investigation and assessment of PV/GxP-related quality events and provide input on proposed CAPAs
Develop, generate and present PV quality/compliance metrics for trending and process improvement
Provide quality oversight on PV-related computer system validation projects and maintenance of systems
Collaborate with Eidos and BridgeBio affiliate companies to develop and continuously improve processes and systems, including policies, SOPs and training plans
Partner cross-functionally to support the business with compliance or quality issues/concerns by ensuring appropriate evaluation, mitigation and escalation to Executive Management
Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed

Benefits

Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities