Quality Unit Process Lead — GMP & Compliance

Regulatory Jobs; Pennsylvania; On-site; USD 85,000 - 110,000; Full time

Job summary

GSK in the United States is seeking a Quality Unit Business Process Specialist to support drug substance operations. You will collaborate daily with manufacturing, quality, IT and engineering to ensure compliant quality processes and SOPs are maintained.

You will oversee quality systems, identify improvement opportunities, coach colleagues, and drive documentation practices while contributing to continuous improvement and readiness for regulatory audits.

Qualifications

• Bachelor's degree and 3+ years in a regulated life sciences setting.
• Experience designing or supporting quality business processes and SOPs.
• Strong understanding of GMP, GDP, and regulatory requirements.

Responsibilities

• Provide quality oversight for drug substance processes and systems, ensuring compliance and acting as a quality contact across sites.
• Support investigations, root cause analysis and CAPA for quality deviations.
• Facilitate risk reviews and train site colleagues on quality processes and documentation.

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 life sciences, engineering, quality, or a related technical field

Tools

SAP ERP

Job description

GSK in the United States is seeking a Quality Unit Business Process Specialist to support drug substance operations. You will collaborate daily with manufacturing, quality, IT and engineering to ensure compliant quality processes and SOPs are maintained.

You will oversee quality systems, identify improvement opportunities, coach colleagues, and drive documentation practices while contributing to continuous improvement and readiness for regulatory audits.