Description
The Deviation Local Process Owner is the local owner of, and subject matter expert of, the deviation and CAPA systems and processes at the Marietta site.
The purpose of the role is to ensure adherence to standards and procedures through oversight of deviation and CAPA processes in support of vaccine manufacturing at the Marietta site.
Responsibilities:
- Act as site-level system owner and SME for assigned deviation and CAPA systems, ensuring the Quality Systems procedures and processes are compliant with requirements.
- Own local deviation and CAPA system performance, including KPI development, trend analysis, escalation, and action plans.
- Lead inspection readiness activities, including system defense, data package preparation, inspector interaction, and response authorship.
- Deliver training activities on deviation and CAPA systems and procedures.
- Mentor and coach site system users, providing technical guidance, system knowledge, and root cause analysis and A.I. investigator instruction.
- Proactively engage operations to positively impact system metrics/KPIs and investigation results.
- Lead system continuous improvement and simplification initiatives with measurable compliance and/or efficiency outcomes.
- Complete all activities in compliance with current GMPs, applicable regulatory requirements, and procedures.
- Collaborate with cross-functional teams to review, investigate, and resolve deviations with strong root cause analysis and corrective actions.
Requirements:
- Bachelor’s degree in Engineering, Pharmacy, Biology, Chemistry, Chemical Engineering, or Life Sciences discipline.
- 5 to 8 + years of pharmaceutical or regulated industry experience within a Quality organization.
- Proven experience leading complex deviation investigations, CAPAs, and system-wide improvements.
- Demonstrated ability to act independently as a quality decision-maker, applying risk-based thinking in alignment with cGMP and regulatory expectations.
- Experience supporting regulatory inspections and authoring or contributing to inspection responses.
- Strong ability to influence cross-functional stakeholders and drive compliance without direct authority.
Preferred Qualifications:
- Experience as a deviation or quality process owner in a large pharmaceutical or life sciences organization.
- Familiarity with quality management systems and electronic deviation tracking tools.
- Experience contributing to quality system harmonization and continuous improvement initiatives.
- Exposure to regulatory inspections and handling audit-related deviation follow-ups.
Benefits: GSK offers a comprehensive benefits program to US employees.