Senior Manager, Quality Compliance
Cytokinetics
August 23, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Key Responsibilities
- Lead and support QA Compliance programs and activities.
- Own end-to-end Product Quality Complaint program (intake, assessment, investigation, resolution) for clinical and commercial products.
- Assess complaint events against MIA/MAH and country/territory requirements; ensure compliant reporting and resolve manufacturing/distribution issues.
- Perform investigation and analysis to determine product defects; monitor events for trends and support QMS improvements.
- Serve as point of contact with contract service providers for complaint handling.
- Monitor regulations/industry standards for emerging requirements; support cross-functional recommendations.
- Support anticipated regulatory inspections (PAI, routine inspections) and partner audits; assist with training for audits/inspections.
- Support Quality Risk Management; establish/improve GMP oversight policies, procedures, and systems.
- Provide technical support for ad hoc investigations/targeted training; develop and interpret quality metrics.
- Participate in cross-functional Quality teams; stay current with GxP and provide timely updates; support internal/external audits.
Qualifications & Experience / Required Skills
- BSc or higher in a relevant scientific discipline.
- 8+ years in pharmaceutical/biopharmaceutical manufacturing and quality.
- Direct experience with Product Quality Complaint handling in the US and EU (other territories preferred).
- Strong knowledge of global GMP/GDP and regulatory trends.
- Experience overseeing external partners/contract organizations.
- Preferred: regulatory authority inspection experience.
- Strong investigation, written/verbal communication, problem-solving, collaboration, decision-making, independence, and organization; Microsoft Office.
Travel
- Up to 10% annually.
- Lead and support QA Compliance programs and activities.
- Own end-to-end Product Quality Complaint program (intake, assessment, investigation, resolution) for clinical and commercial products.
- Assess complaint events against MIA/MAH and country/territory requirements; ensure compliant reporting and resolve manufacturing/distribution issues.
- Perform investigation and analysis to determine product defects; monitor events for trends and support QMS improvements.
- Serve as point of contact with contract service providers for complaint handling.
- Monitor regulations/industry standards for emerging requirements; support cross-functional recommendations.
- Support anticipated regulatory inspections (PAI, routine inspections) and partner audits; assist with training for audits/inspections.
- Support Quality Risk Management; establish/improve GMP oversight policies, procedures, and systems.
- Provide technical support for ad hoc investigations/targeted training; develop and interpret quality metrics.
- Participate in cross-functional Quality teams; stay current with GxP and provide timely updates; support internal/external audits.
Qualifications & Experience / Required Skills
- BSc or higher in a relevant scientific discipline.
- 8+ years in pharmaceutical/biopharmaceutical manufacturing and quality.
- Direct experience with Product Quality Complaint handling in the US and EU (other territories preferred).
- Strong knowledge of global GMP/GDP and regulatory trends.
- Experience overseeing external partners/contract organizations.
- Preferred: regulatory authority inspection experience.
- Strong investigation, written/verbal communication, problem-solving, collaboration, decision-making, independence, and organization; Microsoft Office.
Travel
- Up to 10% annually.