Quality Deviation & CAPA Local Process Owner

GSK; Marietta (PA); On-site; USD 110,000 - 160,000; Full time

Job summary

GSK in Marietta, PA seeks the Deviation Local Process Owner to oversee deviation and CAPA systems, ensuring robust investigations and corrective actions across the site. You will coordinate with quality, manufacturing, regulatory, and supply chain to maintain inspection readiness and continuous improvement.

You will lead training, mentor staff, and drive KPI-based improvements, applying risk-based thinking and strong communication to support regulatory expectations and quality governance.

Qualifications

• Bachelor’s degree and 5–8+ years in pharmaceutical or regulated industry in Quality
• Proven experience leading deviation investigations and CAPAs
• Ability to act independently with risk-based thinking in alignment with cGMP and regulatory expectations
• Experience supporting regulatory inspections and writing inspection responses
• Strong influencing skills across cross-functional teams

Responsibilities

• Act as site-level system owner and SME for deviation and CAPA systems, ensuring compliance
• Own local deviation and CAPA system performance incl. KPI development and trend analysis
• Lead inspection readiness activities and inspector interactions
• Deliver training on deviation and CAPA systems and procedures
• Mentor site system users with root cause analysis and investigation guidance
• Collaborate with operations to improve system metrics and KPIs
• Lead continuous improvement and simplification initiatives with measurable outcomes
• Ensure activities comply with GMP and regulatory requirements and are inspection-ready
• Coordinate with regulatory and audit teams for inspections and follow-ups
• Partner with regional/global quality teams to harmonize 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 in Engineering, Pharmacy, Biology, Chemistry, Chemical Engineering, or Life Sciences

Tools

Quality Management Systems

Electronic deviation tracking tools

Job description

GSK in Marietta, PA seeks the Deviation Local Process Owner to oversee deviation and CAPA systems, ensuring robust investigations and corrective actions across the site. You will coordinate with quality, manufacturing, regulatory, and supply chain to maintain inspection readiness and continuous improvement.

You will lead training, mentor staff, and drive KPI-based improvements, applying risk-based thinking and strong communication to support regulatory expectations and quality governance.