R&D Quality Ops Lead — GMP Compliance & CAPA Expert

GSK; Marietta (PA); On-site; USD 120,000 - 165,000; Full time

Job summary

GSK in the United States seeks a seasoned Quality professional to lead operational quality activities across manufacturing and supplier networks. You will ensure patient safety and reliable supply while collaborating with cross-functional teams in a regulated environment.

You will drive continuous improvement, oversee audits and CAPA, and provide regulatory readiness support for inspections, with a focus on data integrity and GMP/GxP compliance.

Qualifications

• Bachelor’s degree in scientific, engineering, pharmacy, or related discipline.
• Minimum 5 years in Quality roles in highly regulated environments (EMA/FDA/MHRA).
• Fluency in both written and verbal English.
• Experience with cGMP and GMP documentation review and change control.

Responsibilities

• Develop and implement Quality R&D Operations processes.
• Support validation activities for site commissioning and C&Q; lead QMS implementations.
• Review and approve GMP documentation, batch records, deviations and change controls.
• Lead investigations and CAPA; drive corrective actions to closure.
• Coordinate audits and regulatory inspections; communicate findings.
• Provide quality input for product introductions, transfers and changes.
• Monitor quality metrics; escalate risks and drive improvements.

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 scientific field

Job description

GSK in the United States seeks a seasoned Quality professional to lead operational quality activities across manufacturing and supplier networks. You will ensure patient safety and reliable supply while collaborating with cross-functional teams in a regulated environment.

You will drive continuous improvement, oversee audits and CAPA, and provide regulatory readiness support for inspections, with a focus on data integrity and GMP/GxP compliance.