Senior Manager, Quality Compliance
Cytokinetics
12 hours ago
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Key Responsibilities
- Serve as a key contributor on the QA Compliance team; lead and support compliance programs.
- Own the end-to-end product complaints program (intake, assessment, investigation, resolution) for clinical and commercial products.
- Partner with cross-functional teams to assess complaint events against MIA license, MAH, and country/territory requirements, including regulatory reporting and resolution of manufacturing/distribution issues.
- Drive investigation/analysis to determine if products are defective; monitor trends and provide reporting for senior management and QMS improvement.
- Act as point of contact for contract service providers in complaint handling.
- Monitor regulations/industry standards; support assessments to address new requirements/emerging trends.
- Support anticipated regulatory inspections and partner audits (including at contracted organizations) and associated training.
- Support Quality Risk Management and establish/improve policies, procedures, and systems for oversight of internal/external GMP activities.
- Provide technical support for investigations/training; develop meaningful metrics.
- Participate in cross-functional Quality teams; stay current with GxP regulations and provide timely updates; support internal/external audits as needed.
Qualifications & Experience (Required/Preferred)
- BSc or higher in a relevant scientific discipline.
- 8+ years’ pharmaceutical/biopharmaceutical manufacturing and quality experience.
- Required: Product Quality Complaint handling experience in the US and EU. Preferred: other territories.
- Strong knowledge of global GMP/GDP and emerging regulatory trends.
- Experience overseeing external partners/contract organizations.
- Preferred: regulatory authority inspection experience.
- Strong investigation, written/verbal communication, problem-solving; ability to influence across levels; independent, organized, able to manage multiple priorities.
- Proficient in Microsoft Office; travel up to 10% annually.
- Serve as a key contributor on the QA Compliance team; lead and support compliance programs.
- Own the end-to-end product complaints program (intake, assessment, investigation, resolution) for clinical and commercial products.
- Partner with cross-functional teams to assess complaint events against MIA license, MAH, and country/territory requirements, including regulatory reporting and resolution of manufacturing/distribution issues.
- Drive investigation/analysis to determine if products are defective; monitor trends and provide reporting for senior management and QMS improvement.
- Act as point of contact for contract service providers in complaint handling.
- Monitor regulations/industry standards; support assessments to address new requirements/emerging trends.
- Support anticipated regulatory inspections and partner audits (including at contracted organizations) and associated training.
- Support Quality Risk Management and establish/improve policies, procedures, and systems for oversight of internal/external GMP activities.
- Provide technical support for investigations/training; develop meaningful metrics.
- Participate in cross-functional Quality teams; stay current with GxP regulations and provide timely updates; support internal/external audits as needed.
Qualifications & Experience (Required/Preferred)
- BSc or higher in a relevant scientific discipline.
- 8+ years’ pharmaceutical/biopharmaceutical manufacturing and quality experience.
- Required: Product Quality Complaint handling experience in the US and EU. Preferred: other territories.
- Strong knowledge of global GMP/GDP and emerging regulatory trends.
- Experience overseeing external partners/contract organizations.
- Preferred: regulatory authority inspection experience.
- Strong investigation, written/verbal communication, problem-solving; ability to influence across levels; independent, organized, able to manage multiple priorities.
- Proficient in Microsoft Office; travel up to 10% annually.