Operational Quality Lead — GMP Compliance & QA Excellence

GSK

Marietta (PA)

On-site

USD 95,000 - 130,000

Full time

14 days+

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Job summary

GSK US is seeking an on-site Quality Operations professional to provide operational quality oversight at a United States manufacturing site. You will collaborate with production, laboratories, engineering and quality teams to ensure processes are compliant, safe, and reliable, and to maintain cGxP compliance.

The role emphasizes proactive quality culture, batch record review, decision-making, and liaising with QA Systems and QA Product Release.

Qualifications

Bachelor's degree in biology/chemical engineering or related field with technical depth.
2+ years in regulated industry with QA background; biologics preferred.
1+ years GMP/NIH/FDA regulatory experience; batch records review.

Responsibilities

Ensure GMP processes and personnel meet regulatory requirements and inspection readiness.
Maintain shopfloor oversight and support initial management of quality issues.
Provide guidance during GMP activities to detect potential quality issues in real time.
Review cGMP documentation and records; approve deviations and CAPAs.
Support and participate in lot release decisions and internal audits.
Coach employees on procedures and quality culture; conduct floor walks to identify risks.