Quality Assurance Director / Sr. Director (GVP/PV)
Scorpion Therapeutics, San Francisco, CA, United States
Overview
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on BridgeBio is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for patients with genetic diseases and cancers. We build bridges to groundbreaking advancements and empower teams to solve problems. We value curiosity and experimentation, including ethical and thoughtful use of AI to improve clarity, speed, and quality of work. Company overview
BridgeBio has a portfolio of 20+ drug development programs across multiple therapeutic areas, with offices in the U.S. and internationally. For more information, visit bridgebio.com. What You’ll Do
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 BridgeBio affiliates. You will advise internal and external stakeholders on FDA, EMA, MHRA, and international PV regulations and SOPs, and serve as a lead point of contact for GVP regulatory inspection activities. Responsibilities
Provide strategic and operational guidance to drug safety/pharmacovigilance, medical affairs, regulatory, commercial, 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; participate as a lead or co-lead auditor on PV audits as needed; review and approve audit reports and CAPA responses. Maintain and contribute audit and quality data for the Pharmacovigilance System Master File (PSMF). Be a core GVP regulatory inspection team member; lead or participate in inspection readiness activities and host/regulatory inspections; perform quality review of inspection requests; oversee regulatory responses/commitments. Review Quality Agreements and PV/SDEA to assess quality standards and regulatory compliance requirements. Participate in PV/GxP-related quality events and propose 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 system maintenance. Collaborate with Eidos and BridgeBio affiliates to improve processes, policies, SOPs, and training plans. Cross-functional partnership to support the business with compliance issues, with appropriate evaluation, mitigation, and escalation to Executive Management. Stay current with regulatory changes and enforcement actions and recommend policy updates as needed. Where You’ll Work
This is a hybrid role requiring in-office collaboration in our San Francisco Office. Who You Are
Bachelor’s degree with 10-15+ years of GVP quality and compliance experience in a biopharmaceutical company 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; ability to incorporate industry approaches into affiliate programs. Compensation & Benefits
Salary range: $245,000 – $280,000 USD. Actual offer depends on experience and other factors. This role may be located in California. As a global company, our comprehensive benefits may vary by location. USA-based benefits include: Market-leading compensation; 401(k) with employer match; Employee Stock Purchase Program (ESPP); pre-tax commuter benefits; referral bonuses; 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 employer contributions; Flexible Spending Accounts (FSA); fertility & family-forming benefits; expanded mental health support; hybrid work model; flexible PTO and company-paid holidays; paid medical and parental leave. Skill Development & Career Paths Opportunity for growth from discovery to FDA pipelines with ongoing skill development and internal mobility. Career pathing via regular feedback, continuous education, and professional development programs. Recognition and growth opportunities through performance-based rewards.
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Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on BridgeBio is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for patients with genetic diseases and cancers. We build bridges to groundbreaking advancements and empower teams to solve problems. We value curiosity and experimentation, including ethical and thoughtful use of AI to improve clarity, speed, and quality of work. Company overview
BridgeBio has a portfolio of 20+ drug development programs across multiple therapeutic areas, with offices in the U.S. and internationally. For more information, visit bridgebio.com. What You’ll Do
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 BridgeBio affiliates. You will advise internal and external stakeholders on FDA, EMA, MHRA, and international PV regulations and SOPs, and serve as a lead point of contact for GVP regulatory inspection activities. Responsibilities
Provide strategic and operational guidance to drug safety/pharmacovigilance, medical affairs, regulatory, commercial, 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; participate as a lead or co-lead auditor on PV audits as needed; review and approve audit reports and CAPA responses. Maintain and contribute audit and quality data for the Pharmacovigilance System Master File (PSMF). Be a core GVP regulatory inspection team member; lead or participate in inspection readiness activities and host/regulatory inspections; perform quality review of inspection requests; oversee regulatory responses/commitments. Review Quality Agreements and PV/SDEA to assess quality standards and regulatory compliance requirements. Participate in PV/GxP-related quality events and propose 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 system maintenance. Collaborate with Eidos and BridgeBio affiliates to improve processes, policies, SOPs, and training plans. Cross-functional partnership to support the business with compliance issues, with appropriate evaluation, mitigation, and escalation to Executive Management. Stay current with regulatory changes and enforcement actions and recommend policy updates as needed. Where You’ll Work
This is a hybrid role requiring in-office collaboration in our San Francisco Office. Who You Are
Bachelor’s degree with 10-15+ years of GVP quality and compliance experience in a biopharmaceutical company 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; ability to incorporate industry approaches into affiliate programs. Compensation & Benefits
Salary range: $245,000 – $280,000 USD. Actual offer depends on experience and other factors. This role may be located in California. As a global company, our comprehensive benefits may vary by location. USA-based benefits include: Market-leading compensation; 401(k) with employer match; Employee Stock Purchase Program (ESPP); pre-tax commuter benefits; referral bonuses; 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 employer contributions; Flexible Spending Accounts (FSA); fertility & family-forming benefits; expanded mental health support; hybrid work model; flexible PTO and company-paid holidays; paid medical and parental leave. Skill Development & Career Paths Opportunity for growth from discovery to FDA pipelines with ongoing skill development and internal mobility. Career pathing via regular feedback, continuous education, and professional development programs. Recognition and growth opportunities through performance-based rewards.
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