Associate Director, QA CSV (South San Fran)

Associate Director, QA CSV (South San Fran) SimulStat South San Francisco, CA Job Details Contract 11 hours ago Qualifications Medical software Enterprise software TrackWise GMP Pharmaceutical company experience SaaS platforms Biomedical regulatory compliance Clinical quality assurance standards

Full Job Description Associate Director, QA Computer System Validation 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 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 Basic Requirements:

10+ years of experience supporting computerized systems within regulated pharmaceutical, biotechnology, medical device, or life sciences environments. Pharmaceutical Industry Experience Required Strong GCP/GMP knowledge

Clinical Systems:

Medidata Rave, CTMS, eTMF, SaaS platforms TraceLink Experience Required Trackwise Experience Required •This role is a 12-month contract-to-hire opportunity requiring 3 days per week on-site•