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
Requirements
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, 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 to problem-solve
Must have strong interpersonal and communication skills, and the ability to work with multiple cross-functional teams
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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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Benefits
Equity / stock options
Additional Information
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.
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.
Cytokinetics · Radnor, PA