Deviation Local Process Owner
Core
Local owner and subject matter expert for deviation and CAPA systems and processes at the Marietta vaccine manufacturing site, ensuring adherence to standards and procedures to resolve/prevent quality issues.
Role type
Senior IC Quality Systems Owner (Pharmaceutical Manufacturing)
Builds
Robust deviation and CAPA systems for vaccine manufacturing operations
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Root cause analysis, CAPA management, GMP compliance, Inspection readiness, KPI development, Trend analysis, Cross-functional collaboration, Training delivery, System harmonization
Preferred skills
Deviation process ownership in large pharma, Electronic deviation tracking tools, Quality system harmonization, Audit follow-up experience
Technologies
Electronic deviation tracking tools, Digital solutions
Responsibilities
Own local deviation and CAPA system performance including KPI development and trend analysis; Lead inspection readiness activities including system defense and data package preparation; Mentor and coach site system users on root cause analysis; Collaborate with cross-functional teams to investigate and resolve deviations; Drive continuous improvement initiatives for quality systems.
Seniority
Senior, hands-on IC