Quality Deviation & CAPA Lead — Local Process Owner

GlaxoSmithKline; Marietta (PA); On-site; USD 120,000 - 150,000; Full time

Job summary

GlaxoSmithKline seeks a Deviation Local Process Owner for the Marietta site to own deviation and CAPA systems, ensuring adherence to GMPs and robust investigations. You will drive continuous improvement, mentor users, and coordinate readiness for regulatory inspections across quality, manufacturing, and regulatory teams.

You will lead system improvements, data analysis, and training while collaborating with cross-functional partners to ensure efficient deviation handling and CAPA execution in a

Qualifications

• Bachelor's degree required or equivalent experience in a related field.
• 5–8+ years in pharmaceutical/regulated quality environment with ownership of quality systems.
• Experience supporting regulatory inspections and contributing to inspection responses.
• Strong knowledge of GMP and U.S. regulatory quality expectations; ability to lead investigations and CAPA.
• Ability to influence cross-functional teams and drive compliance without direct authority.

Responsibilities

• Act as site-level system owner and SME for deviation and CAPA systems, ensuring compliant Quality Systems procedures and processes.
• Deliver training activities on deviation and CAPA systems (Qualified Trainer).
• Mentor site users with root cause analysis and investigation instruction; drive system improvements and KPI/performance metrics.
• Ensure compliance with GMPs and readiness for inspections; oversee risk-based actions and root cause analyses.
• Collaborate with cross-functional teams to investigate deviations and implement corrective actions; coordinate with regulatory and audit teams.

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

Job description

GlaxoSmithKline seeks a Deviation Local Process Owner for the Marietta site to own deviation and CAPA systems, ensuring adherence to GMPs and robust investigations. You will drive continuous improvement, mentor users, and coordinate readiness for regulatory inspections across quality, manufacturing, and regulatory teams.

You will lead system improvements, data analysis, and training while collaborating with cross-functional partners to ensure efficient deviation handling and CAPA execution in a