Onsite GMP Quality Lead — CAPA, Batch Release & Compliance

GSK; Marietta (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

GSK US is seeking an on-site Quality Assurance professional at a United States manufacturing site to provide operational quality oversight. You will partner with production, laboratories, engineering and quality teams to ensure processes meet cGxP standards and regulatory requirements, reviewing batch records and approvals, and escalating quality risks.

You'll coach staff on quality best practices, support deviations and CAPA, and help maintain inspection readiness while fostering a culture of

Qualifications

• Bachelor’s degree in biology, chemical engineering, life sciences or related field.
• 2+ years experience in regulated industry with strong QA background.
• Experience with GMPs, FDA and regulatory compliance in pharmaceutical facilities.
• Experience with validation principles, aseptic processing, and batch record review.

Responsibilities

• Ensure GMP processes and personnel adhere to GMP and regulatory requirements.
• Maintain shopfloor oversight and support quality issues.
• Provide guidance during GMP activities to detect issues in real-time.
• Perform spot-checks across production and labs for compliance.
• Review cGMP docs and batch records following ALCOA+ data integrity.
• Review deviations and CAPA plans; approve docs.
• Ensure GMP, validation, safety and environmental regs are met.
• Coach employees on procedures and quality culture.
• On-floor quality oversight with regular walkthroughs.
• Support lot release, self-inspections, internal audits.
• Review and approve GMP docs; investigate issues and CAPA.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Bachelor’s degree in biology, chemical engineering, life sciences or related field

Job description

GSK US is seeking an on-site Quality Assurance professional at a United States manufacturing site to provide operational quality oversight. You will partner with production, laboratories, engineering and quality teams to ensure processes meet cGxP standards and regulatory requirements, reviewing batch records and approvals, and escalating quality risks.

You'll coach staff on quality best practices, support deviations and CAPA, and help maintain inspection readiness while fostering a culture of