Associate Director

Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will hare strategic responsibility for the QA CSV function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.

Responsibilities

• Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV strategies
• Actively support the CSV functional strategies and multi-year roadmap, and actively take part in developing parts of the strategy
• Lead internal and contract resources to manage CSV activities and ensure adequate support to meet business needs
• Participate in global/enterprise wide GxP-CSV projects and contributes 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 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 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 compliance guidance, identify issues and support continuous improvement
• Perform CSV 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

Qualifications

• 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, SAS, ERP, 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

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer