Associate Director, QA Computer System Validation

Associate Director, Computer System Validation

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

• Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV / CSA strategies
• Actively support the CSV / CSA functional strategies and multi-year roadmap, and actively take part in developing parts of the strategy
• Lead internal and contract resources to manage CSV / CSA activities and ensure adequate support to meet business needs
• Participate in global/enterprise wide GxP-CSV / CSA projects and contribute to computer system validation working groups and strategies
• Manage risk assessments with functional teams to assess system risks and develop mitigations
• Provide input to CSV / CSA documentation and oversee the execution of qualification/validation activities
• Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports)
• Participate in vendor assessments and/or audits. Manage and/or lead CSV / CSA routine and complex audits including but not limited to internal processes, vendors and business partners
• Interact regularly with members of QA and other GXP functions to provide expert CSV / CSA compliance guidance, identify issues and support continuous improvement
• Perform CSV / CSA inspection readiness preparations and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable
• Update and/or create computer system related policies, procedures, templates, forms, etc.
• Provide guidance and expertise on the validation approach in compliance with regulations to project teams as necessary
• Lead new system selection processes including requirement gathering, RFP development, and software vendor selection
• Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations
• Identify and implement process improvements against industry best practices, regulatory guidelines and requirements
• Review and approve computer system SOPs, change controls, deviations, and CAPAs

• Bachelor's degree in engineering, science or equivalent technical discipline with 10+ years of experience in quality assurance, computer system validation/qualification, or related areas
• Experience with systems such as Veeva Vault eQMS, Veeva eTMF, CTMS, Medidata Rave, SAS, Trace Link, Oracle Fusion
• In depth knowledge of CFR 21 Parts 11, GAMP5, Annex 11 and data integrity requirements, standards and guidelines
• Strong background and understanding of EMA, MHRA, FDA and other regulations
• In depth knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP)
• Detail-oriented, well organized, and able to assume responsibility for multiple projects independently
• Experience in authoring/reviewing/approving validation documentation
• In depth knowledge of software development lifecycle (SDLC) model
• Knowledge in validation practices of various computerized systems (configurable software, non-configurable software, off-the-shelf software)
• Data migration experience
• Experience with vendor audits
• Ability to work in a collaborative team environment is essential, with a customer focused approach
• Strong decision maker with the ability to utilize critical thinking to problem-solve
• Must have strong interpersonal and communication skills, and the ability to work with multiple cross-functional teams

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $184,500 - $215,250 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

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