Senior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management)
Arrowhead Pharmaceuticals
August 30, 2026
On-site
Los Angeles, CA
Operations
The Position
Provide strategic leadership for global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs by overseeing inspection readiness, regulatory inspection management, internal quality audits, and partner audit activities. Lead the Inspection Readiness and Management Program as the primary Inspection Lead responsible for planning, hosting, facilitating, and directing FDA (BIMO), MHRA, PMDA, EMA, and other Health Authority inspections, including PV post-marketing inspections. Lead and execute a risk-based internal GCP/GVP audit program and oversee partner/alliance audits.
Responsibilities
- Own the global GCP/GVP Inspection Readiness Program and establish governance for continuous inspection readiness.
- Serve as primary Inspection Lead/Host for Health Authority inspections, including PV post-marketing surveillance.
- Lead inspection planning (scope, logistics, agendas, rooms, virtual platforms, document management, communication plans).
- Facilitate inspection management before/during/after; align with stakeholders and executive leadership.
- Chair daily inspection meetings, back-room activities, issue escalation, risk assessments, and executive debriefs.
- Prepare SMEs/executives via mock inspections, interview coaching, simulations, and readiness assessments.
- Oversee regulatory document requests and quality review/consistency of inspection responses.
- Lead responses to Form FDA 483 observations and equivalent findings, CAPAs, effectiveness checks, and commitments.
- Provide strategic oversight of CROs, vendors, and business partners.
- Develop and present inspection readiness dashboards/KPIs/risk metrics/trends.
- Implement new global regulatory expectations (ICH E6(R3), FDA/EMA/MHRA/PMDA/GVP).
- Drive continuous improvement initiatives for inspection readiness and quality systems.
- Develop/lead risk-based GCP/GVP internal audit program, including CAPA oversight.
- Lead/host partner, alliance, licensing, and due diligence audits.
Requirements
- Bachelor’s degree in life sciences, pharmacy, chemistry, or related field.
- 8+ years in regulated pharmaceutical/biotech; 5+ years in leadership with increasing responsibility.
- Full knowledge of GxP (GCP/GVP), ICH guidelines, and ISO standards.
- Strong project management, organization, execution, and priority-setting skills.
- Strategic, continuous-improvement mindset; anticipates and resolves problems.
- Excellent communication/interpersonal/leadership skills; ability to influence stakeholders.
- Experience with EMDS/EQMS.
- Business travel ~25–30%.
Preferred
- Advanced degree in life science.
Benefits/Compensation
- California pay range: $145,000 USD - $170,000 USD.
Application instructions / location
- Based in Pasadena; expectation to be in office 5 days a week.
Provide strategic leadership for global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs by overseeing inspection readiness, regulatory inspection management, internal quality audits, and partner audit activities. Lead the Inspection Readiness and Management Program as the primary Inspection Lead responsible for planning, hosting, facilitating, and directing FDA (BIMO), MHRA, PMDA, EMA, and other Health Authority inspections, including PV post-marketing inspections. Lead and execute a risk-based internal GCP/GVP audit program and oversee partner/alliance audits.
Responsibilities
- Own the global GCP/GVP Inspection Readiness Program and establish governance for continuous inspection readiness.
- Serve as primary Inspection Lead/Host for Health Authority inspections, including PV post-marketing surveillance.
- Lead inspection planning (scope, logistics, agendas, rooms, virtual platforms, document management, communication plans).
- Facilitate inspection management before/during/after; align with stakeholders and executive leadership.
- Chair daily inspection meetings, back-room activities, issue escalation, risk assessments, and executive debriefs.
- Prepare SMEs/executives via mock inspections, interview coaching, simulations, and readiness assessments.
- Oversee regulatory document requests and quality review/consistency of inspection responses.
- Lead responses to Form FDA 483 observations and equivalent findings, CAPAs, effectiveness checks, and commitments.
- Provide strategic oversight of CROs, vendors, and business partners.
- Develop and present inspection readiness dashboards/KPIs/risk metrics/trends.
- Implement new global regulatory expectations (ICH E6(R3), FDA/EMA/MHRA/PMDA/GVP).
- Drive continuous improvement initiatives for inspection readiness and quality systems.
- Develop/lead risk-based GCP/GVP internal audit program, including CAPA oversight.
- Lead/host partner, alliance, licensing, and due diligence audits.
Requirements
- Bachelor’s degree in life sciences, pharmacy, chemistry, or related field.
- 8+ years in regulated pharmaceutical/biotech; 5+ years in leadership with increasing responsibility.
- Full knowledge of GxP (GCP/GVP), ICH guidelines, and ISO standards.
- Strong project management, organization, execution, and priority-setting skills.
- Strategic, continuous-improvement mindset; anticipates and resolves problems.
- Excellent communication/interpersonal/leadership skills; ability to influence stakeholders.
- Experience with EMDS/EQMS.
- Business travel ~25–30%.
Preferred
- Advanced degree in life science.
Benefits/Compensation
- California pay range: $145,000 USD - $170,000 USD.
Application instructions / location
- Based in Pasadena; expectation to be in office 5 days a week.