QA Validation Strategy Lead (Assoc. Director) | CSV & GxP

Franklin Bio Lab; King of Prussia (PA); Sur place; USD 140 000 - 190 000; Plein temps

Avantages offerts par ce poste

401(k)

401(k) Matching

Health insurance

Vision insurance

Health Savings Account and Flexible Sp

Paid Time-Off

Company Holidays

Personal Floating Holidays

Short-Term and Long-Term Disability

Life and AD&D insurance

Résumé du poste

Franklin Biolabs is seeking an Assoc. Director, QA Validation for on-site work at our King of Prussia, PA location. Lead validation projects for equipment and enterprise systems, serving as the CSV reviewer for critical documents and ensuring alignment with GxP requirements.

You will drive CV life-cycle activities, manage internal and contract teams, and support regulatory inspections with strong communication across vendors and clients.

Qualifications

• BS/BA in Computer Sciences, Life Sciences or Engineering required.
• 7–10 years direct CSV experience in biopharmaceutical or biotech.
• No formal certifications required.

Responsabilités

• Project lead validation projects for equipment and enterprise systems, ensuring on-schedule and compliant closure.
• Act as the QA CSV reviewer and approver for critical CSV docs and reports.
• Contribute to the execution of GxP computer system validation lifecycles and CSV strategies.
• Lead and manage internal and contract resources to support CSV needs.
• Participate in audits, vendor assessments, and regulatory interactions to ensure compliance.
• Provide CSV guidance to QA and GxP teams; respond to inspection findings.
• Update CSV policies, procedures, and templates per latest regulations.

Connaissances

CSV expertise

GxP knowledge

Team leadership

Regulatory interaction

Formation

BS/BA in Computer Sciences, Life Sciences or Engineering

Outils

Veeva Quality Cloud

Description du poste

Franklin Biolabs is seeking an Assoc. Director, QA Validation for on-site work at our King of Prussia, PA location. Lead validation projects for equipment and enterprise systems, serving as the CSV reviewer for critical documents and ensuring alignment with GxP requirements.

You will drive CV life-cycle activities, manage internal and contract teams, and support regulatory inspections with strong communication across vendors and clients.