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

About the role

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.

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

Where You’ll Work

This is a hybrid role and will require in-office collaboration in our San Francisco Office.

Who You Are

• 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

Pay

$245,000 - $280,000 USD

Schedule

This is a hybrid role and will require in-office collaboration in our San Francisco Office.