R&D Quality Operations Lead — GMP & Compliance

GSK plc; Marietta (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

GSK is seeking an experienced quality professional to lead operational quality activities across US manufacturing and supplier partners, ensuring patient safety and reliable supply. The role requires coordinating with manufacturing, regulatory, and external teams to simplify processes and drive continuous improvement.

The successful candidate will have deep knowledge of GMP, CAPA, change control, and quality systems, with a focus on aseptic and regulatory compliance across multiple sites.

Qualifications

• Bachelor's degree in scientific, engineering, pharmacy, or related discipline required.
• Minimum 5 years of experience in Quality roles in a highly regulated environment (EMA/FDA/MHRA).
• Experience with cGMP and quality systems including CAPA, change control, and document control.

Responsibilities

• Develop and implement Quality R&D Operations processes; support site commissioning and qualification (C&Q).
• Approve GMP documentation and participate in investigations, CAPA, and corrective actions.
• Lead audits/assessments and manage regulatory inspections and risk management.
• Support Quality Management System implementation, provide SME input, and train customers and partners on compliance practices.

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

Job description

GSK is seeking an experienced quality professional to lead operational quality activities across US manufacturing and supplier partners, ensuring patient safety and reliable supply. The role requires coordinating with manufacturing, regulatory, and external teams to simplify processes and drive continuous improvement.

The successful candidate will have deep knowledge of GMP, CAPA, change control, and quality systems, with a focus on aseptic and regulatory compliance across multiple sites.