Associate Director, QA Computer System 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 share 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

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