Cytokinetics

Associate Director, QA Computer System Validation

South San Francisco, California · Director

Sponsorship not specified$185k-$215kDetected 31 days ago

GCPComplianceGMPFDA RegulatoryPharmacovigilanceSASLeadershipCommunicationCritical ThinkingGxP

About the role

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.
Our employees come from different backgrounds, and we celebrate those differences.
If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

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
Manage risk assessments with functional teams to assess system risks and develop mitigations
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.
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

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
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)
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)
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
Strong background and understanding of EMA, MHRA, FDA and other regulations
Detail-oriented, well organized, and able to assume responsibility for multiple projects independently
Data migration experience

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.

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 listing is sourced directly from Cytokinetics's careers page and normalized into a canonical job model.