Overview:
The Associate Director, CSV will oversee the compliance of computer system validation (CSV) efforts as part of the quality assurance team. This role ensures the execution of CSV strategies and supports cross-functional initiatives related to GxP systems. The position involves driving complex CSV projects and providing leadership across the organization.
Responsibilities:
- Lead the implementation and oversight of GxP computer system validation lifecycles and QA-CSV strategies.
- Contribute to the development of multi-year functional strategies and roadmaps for CSV.
- Manage internal and external resources to ensure alignment with business needs.
- Participate in global GxP-CSV projects and lead validation working groups.
- Assess system risks, develop mitigation plans, and ensure validation documentation is complete and compliant.
- Oversee audits, including vendor assessments, internal processes, and business partner reviews.
- Support regulatory inspections and lead responses to any findings.
- Update policies, procedures, and guidelines related to computer systems.
- Provide validation expertise to cross-functional project teams.
Qualifications:
- Bachelor's degree in engineering, science, or a related field with 10+ years of experience in quality assurance and CSV.
- Experience with GxP systems (e.g., Veeva Vault, ERP, Oracle Fusion) and regulatory standards (CFR 21 Part 11, GAMP5, Annex 11).
- Strong knowledge of FDA, EMA, MHRA regulations, and GxP practices (GCP, GMP, GVP, GLP).
- Experience leading system qualification and validation projects, including audits and risk assessments.
- Strong communication skills and the ability to collaborate across teams.
