Associate Director, QA Computer Systems Validation

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

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 / CSA 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 / 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 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 / 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

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, TraceLink, 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 t