Associate Director, QA Computer System Validation
Cytokinetics
June 26, 2026
Remote friendly (San Francisco Bay Area)
United States
IT
Responsibilities:
- Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV/CSA strategies
- Support CSV/CSA functional strategies and multi-year roadmap; help develop strategy
- Lead internal and contract resources to manage CSV/CSA activities
- Participate in global/enterprise GxP-CSV/CSA projects and validation working groups
- Manage risk assessments with functional teams; develop mitigations
- Provide input to CSV/CSA documentation and oversee execution of qualification/validation activities
- Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports)
- Participate in vendor assessments/audits; manage/lead routine and complex CSV/CSA audits
- Provide CSV/CSA compliance guidance and support continuous improvement
- Prepare for CSV/CSA inspections and support regulatory agency inspections
- Update/create computer system policies, procedures, templates, forms
- Provide validation approach guidance to project teams for regulatory compliance
- Lead new system selection (requirements gathering, RFP development, vendor selection)
- Develop/evaluate quality processes and system standards for compliance
- Identify and implement process improvements
- Review/approve computer system SOPs, change controls, deviations, and CAPAs
Qualifications:
- Bachelor’s degree in engineering, science, or equivalent; 10+ years in QA, CSV/qualification, or related areas
- Experience with Veeva Vault eQMS, Veeva eTMF, CTMS, Medidata Rave, SAS, TraceLink, Oracle Fusion
- In-depth knowledge of CFR 21 Part 11, GAMP5, Annex 11, and data integrity
- Strong knowledge of EMA, MHRA, FDA and other regulations; GCP, GVP, GMP, GDP, GLP
- Detail-oriented; able to manage multiple projects independently
- Experience authoring/reviewing/approving validation documentation
- In-depth SDLC knowledge; validation practices for configurable, non-configurable, and off-the-shelf software
- Data migration experience; vendor audit experience
- Strong decision-making, critical thinking, and communication/interpersonal skills with cross-functional teams
- Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV/CSA strategies
- Support CSV/CSA functional strategies and multi-year roadmap; help develop strategy
- Lead internal and contract resources to manage CSV/CSA activities
- Participate in global/enterprise GxP-CSV/CSA projects and validation working groups
- Manage risk assessments with functional teams; develop mitigations
- Provide input to CSV/CSA documentation and oversee execution of qualification/validation activities
- Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports)
- Participate in vendor assessments/audits; manage/lead routine and complex CSV/CSA audits
- Provide CSV/CSA compliance guidance and support continuous improvement
- Prepare for CSV/CSA inspections and support regulatory agency inspections
- Update/create computer system policies, procedures, templates, forms
- Provide validation approach guidance to project teams for regulatory compliance
- Lead new system selection (requirements gathering, RFP development, vendor selection)
- Develop/evaluate quality processes and system standards for compliance
- Identify and implement process improvements
- Review/approve computer system SOPs, change controls, deviations, and CAPAs
Qualifications:
- Bachelor’s degree in engineering, science, or equivalent; 10+ years in QA, CSV/qualification, or related areas
- Experience with Veeva Vault eQMS, Veeva eTMF, CTMS, Medidata Rave, SAS, TraceLink, Oracle Fusion
- In-depth knowledge of CFR 21 Part 11, GAMP5, Annex 11, and data integrity
- Strong knowledge of EMA, MHRA, FDA and other regulations; GCP, GVP, GMP, GDP, GLP
- Detail-oriented; able to manage multiple projects independently
- Experience authoring/reviewing/approving validation documentation
- In-depth SDLC knowledge; validation practices for configurable, non-configurable, and off-the-shelf software
- Data migration experience; vendor audit experience
- Strong decision-making, critical thinking, and communication/interpersonal skills with cross-functional teams