Associate Director, QA Validation — Onsite CSV Leader (Biotech)

Franklin Biolabs; King of Prussia (PA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

401(k)

401(k) Matching

Health insurance

Vision insurance

Paid Time-Off

Short-Term Disability

Long-Term Disability

Life and AD&D insurance

Job summary

Franklin Biolabs in King of Prussia, PA seeks an Associate Director of Quality Assurance Validation to lead CSV programs across equipment and enterprise systems on site. You will act as the QA CSV reviewer and approver for critical documentation, driving GMP/GxP compliance and shaping CSV strategies to meet company goals.

The role requires 7–10 years of biopharma CSV experience, a BS/BA in CS, life sciences or engineering, and proven leadership of cross-functional teams.

Qualifications

• 7–10 years of direct biopharma CSV experience.
• Deep CSV knowledge in biopharma/biotech sectors.
• Experience with Veeva Quality Cloud systems.

Responsibilities

• Lead validation projects for equipment and enterprise systems.
• Act as the QA CSV reviewer/approver for CSV docs and reports.
• Contribute to the execution of GxP computer system validation lifecycles and QA-CSV strategies.
• Lead internal and contract resources to support CSV activities.
• Participate in audits and vendor assessments to evaluate compliance with GxP and CSV requirements.
• Provide CSV guidance to QA and GxP functions and prepare responses to inspection findings.

Skills

CSV expertise

GxP compliance

Veeva Quality Cloud

Project leadership

Communication skills

Education

BS/BA in Computer Sciences, Life Sciences or Engineering

Tools

Veeva Quality Cloud

Job description

Franklin Biolabs in King of Prussia, PA seeks an Associate Director of Quality Assurance Validation to lead CSV programs across equipment and enterprise systems on site. You will act as the QA CSV reviewer and approver for critical documentation, driving GMP/GxP compliance and shaping CSV strategies to meet company goals.

The role requires 7–10 years of biopharma CSV experience, a BS/BA in CS, life sciences or engineering, and proven leadership of cross-functional teams.