On-Site Quality & Compliance Lead - GMP, Biologics

OneWe Reach; Pennsylvania; On-site; USD 90,000 - 130,000; Full time

Job summary

GSK in the United States seeks an experienced QA professional to provide operational quality oversight at a manufacturing site. You will ensure cGxP compliance, perform batch record reviews, and lead quality decisions while coaching teams on best practices.

Role emphasizes hands-on problem solving, collaboration with operations, and continuous improvement to safeguard product quality and patient safety. On-site presence is required at the site for production and laboratory activities.

Qualifications

• Bachelor's degree in biology, chemical engineering, life sciences field or related with technical depth.
• 2+ years in regulated industry with quality assurance background.
• 1+ years with GMPs, FDA regulations, and quality systems.

Responsibilities

• Ensure GMP processes and personnel adhere to current GMP and regulatory requirements.
• Oversee quality issues on the shop floor and escalate as needed.
• Provide guidance during GMP activities to detect issues and intervene.
• Perform spot-checks of production and lab activities for compliance.
• Review cGMP documentation and approve batch records and deviations.
• Approve deviations and CAPA plans; review related documents.
• Ensure compliance with safety, regulatory, and data integrity standards.
• Coach employees on procedures and quality behavior.
• On-the-floor quality oversight with regular walk-throughs.

Skills

Data Integrity

GxP Regulations

Quality Assurance

Problem Solving

Technical Writing

Detail-Oriented

Education

Bachelor's degree in biology/life sciences

Job description

GSK in the United States seeks an experienced QA professional to provide operational quality oversight at a manufacturing site. You will ensure cGxP compliance, perform batch record reviews, and lead quality decisions while coaching teams on best practices.

Role emphasizes hands-on problem solving, collaboration with operations, and continuous improvement to safeguard product quality and patient safety. On-site presence is required at the site for production and laboratory activities.