Quality Unit Specialist: Drug Substance Process Improvement

GSK; Marietta (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

GSK is seeking a Quality Unit Business Process Specialist to support drug substance operations at a U.S. site. You will collaborate daily with manufacturing, quality, IT, and engineering to ensure quality systems run smoothly and compliantly.

You’ll oversee quality documentation, risk assessments, CAPAs, and SOPs while coaching colleagues to uphold high GMP standards. This on-site role offers growth opportunities within a global biopharma company.

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or a related technical field.
• Minimum 3 years’ experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment.
• Experience designing, implementing, or supporting quality business processes, preferably involving SAP or similar ERP.
• Practical knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory compliance.
• Experience participating in change control, CAPA, deviations, or quality investigations.
• Strong verbal and written communication skills and ability to work collaboratively on-site with cross-functional teams.

Responsibilities

• Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards.
• Act as a key quality contact for cross-functional teams and sites on master data, process changes, and procedural questions.
• Develop, review, and maintain quality unit business process documentation and standard operating procedures (SOPs).
• Support investigations, root cause analysis, and corrective and preventive actions related to quality deviations and process issues.
• Facilitate quality impact assessments and risk reviews for process and system changes.
• Train and coach site colleagues on quality processes, documentation practices, and compliance requirements.

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 related technical field

Tools

SAP

Job description

GSK is seeking a Quality Unit Business Process Specialist to support drug substance operations at a U.S. site. You will collaborate daily with manufacturing, quality, IT, and engineering to ensure quality systems run smoothly and compliantly.

You’ll oversee quality documentation, risk assessments, CAPAs, and SOPs while coaching colleagues to uphold high GMP standards. This on-site role offers growth opportunities within a global biopharma company.