GSK
Deviation Local Process Owner
USA - Pennsylvania - Marietta · Hybrid (Remote & On-site) · Full-time · Posted Oct 20, 2026
- Experience
- 5 to 8 + years of pharmaceutical or regulated industry experience within a Quality organization.
- Education
- Bachelor’s degree required; a degree in another discipline may be considered with sufficient experience, but a bachelor’s degree is required.
About the job
Owns local deviation and CAPA systems and processes, ensuring compliant investigations, inspection readiness, training, and continuous improvement at the Marietta site and other U.S. local sites.
What you'll do
- Lead deviation and CAPA system performance, including KPIs, trend analysis, escalation, and action plans.
- Lead inspection readiness and support inspections, including system defense, data packages, inspector interaction, and response authorship.
- Train and coach employees, lead investigations and corrective actions, and drive system improvements with cross-functional teams.
What they ask for
- Bachelor’s degree in Engineering, Pharmacy, Biology, Chemistry, Chemical Engineering, or Life Sciences; another discipline may be considered with sufficient experience, but a bachelor’s degree is required.
- 5 to 8 + years of pharmaceutical or regulated industry experience within a Quality organization, with demonstrated ownership of quality systems.
- Proven experience leading complex deviation investigations, CAPAs, and system-wide improvements; ability to make independent quality decisions using risk-based thinking aligned with cGMP and regulatory expectations.
- Experience supporting regulatory inspections and authoring or contributing to inspection responses; experience with data trending, KPI development, and management review reporting.
Nice to have
- 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.
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