Job Type: Contract
Contract Length: 6 months
Pay Range: $90-$150/hour
Start Date: ASAP
Location: Remote (Must work PST)
About the Opportunity:
Our client, a leader in the pharmaceutical/biotechnology industry, is looking for a skilled Senior Manager, Computer System Validation (CSV) to join their team for a 6-month engagement. This project involves leading the validation strategy and execution across GxP systems, ensuring continuous compliance with global regulatory expectations. This is a high-impact, autonomous role that requires a self-motivated professional who can hit the ground running and deliver results quickly.
Key Responsibilities & Deliverables:
This role is focused on the successful completion of specific tasks and deliverables. Your responsibilities will include:
- Lead validation strategy and execution across GxP systems lifecycle, ensuring systems remain in a validated, audit-ready state.
- Drive risk-based validation approaches (CSV/CSA) and author, review, and approve validation documentation, including plans, protocols, and reports.
- Ensure compliance with applicable regulatory requirements and industry standards, including 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Lead deviation, CAPA, and remediation activities related to CSV and support system periodic reviews.
- Partner with IS/IT, QA, and business stakeholders to support internal and external audits and regulatory inspections.
We are looking for someone with a proven track record of successful contract engagements. The ideal candidate will have:
- 10+ years of experience in GxP Computer System Validation (CSV) within pharmaceutical or biotechnology environments.
- Deep expertise in GxP regulations, including 21 CFR Part 11, Annex 11, and GAMP 5. This isn't a learning role—you need to be a subject matter expert.
- Proven ability to lead validation strategy and execute hands-on when needed.
- Experience validating GxP systems (quality, clinical, manufacturing) and supporting regulatory inspections and audits.
- Demonstrated ability to work autonomously and manage your own time effectively to meet project goals.
- Strong communication skills to provide clear and concise status updates to the project team.
