Senior QA Validation Lead - Biotech CSV

Automatic Data Processing, Inc.; King of Prussia (PA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

401(k)

401(k) Matching

Health insurance

Vision insurance

Health Savings Account and Flexible Sp

Personal Floating Holidays

Short-Term and Long-Term Disability

Life and AD&D insurance (Group & Vol)

Job summary

Franklin Biolabs in King of Prussia, PA seeks an Associate Director, QA Validation to lead CSV validation projects, act as QA CSV reviewer, and drive GxP validation strategies. This role ensures ongoing compliance and successful audits.

The position requires a BS/BA in a science or engineering field with 7–10 years in biopharma CSV, and offers on-site work at our Discovery Labs location with cross-functional collaboration across teams.

Qualifications

• Minimum of BS/BA degree in Computer Sciences, Life Sciences or Engineering, required.
• 7-10 years of direct experience in biopharmaceutical or biotech CSV, or equivalent.
• Formal certifications or education required: None.

Responsibilities

• Project lead validation projects for equipment and enterprise systems. Ensuring validation projects stay on schedule, compliant and drive to closure.
• Act as the QA CSV reviewer and approver for critical CSV documentation, including specifications, validation protocols, and reports, ensuring compliance with industry regulations.
• Contribute to the execution of GxP computer system validation lifecycles and QA-CSV strategies to meet company goals.
• Lead and manage both internal and contract resources to provide effective support for CSV-related business needs.
• Participate in routine and complex internal and external audits, including vendor assessments, to evaluate compliance with GxP regulations and CSV requirements.
• Act as a CSV compliance expert, offering guidance to the quality assurance team and GxP functions.
• Prepare and support regulatory inspection and client audit activities, including the preparation of responses to inspection findings related to CSV.
• Update and develop CSV-related policies, procedures, and templates based on the latest regulatory requirements and industry trends.
• Proactively identify opportunities for process improvements within CSV activities, ensuring alignment with industry best practices.
• Review and approve equipment in BMRAM. Ensuring information is accurate and complete.
• Continuously monitor all validated system, ensuring they remain in a validated state.
• Perform additional duties as assigned.

Skills

CSV

Computer system validation

GxP

Veeva R Quality Cloud

Regulatory compliance

Communication

Collaboration

Education

BS/BA degree in Computer Sciences, Life Sciences or Engineering

Tools

Veeva R Quality Cloud

Job description

Franklin Biolabs in King of Prussia, PA seeks an Associate Director, QA Validation to lead CSV validation projects, act as QA CSV reviewer, and drive GxP validation strategies. This role ensures ongoing compliance and successful audits.

The position requires a BS/BA in a science or engineering field with 7–10 years in biopharma CSV, and offers on-site work at our Discovery Labs location with cross-functional collaboration across teams.