Deviation & CAPA Quality Lead — Site Owner

GSK; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

GSK at the Marietta site is seeking a Deviation Local Process Owner to oversee deviation and CAPA systems in vaccine manufacturing. The role ensures adherence to Quality Systems procedures, drives KPI development, trend analysis, and corrective actions, and maintains inspection readiness across the site.

You will collaborate with quality, manufacturing, regulatory, and cross-functional teams to resolve quality issues, lead investigations, and implement robust preventive actions, aiming to

Qualifications

• Bachelor's degree in an engineering, pharmacy, biology, chemistry, chemical engineering or life sciences discipline.
• 5–8+ years of pharmaceutical or regulated industry quality experience with ownership of quality systems.
• Proven experience leading complex deviation investigations, CAPAs and system-wide improvements.

Responsibilities

• Act as site-level SME for deviation and CAPA systems; manage KPI development, trend analysis, escalation and action plans.
• Lead inspection readiness activities; prepare data packages; interact with inspectors; author responses.
• Deliver training activities on deviation and CAPA systems; mentor users; perform root cause analysis and guide AI investigator training.
• Ensure compliance with current GMPs and regulatory requirements; maintain inspection readiness and certify quality system actions.
• Collaborate with cross-functional teams to review, investigate and resolve deviations; monitor trends and share learnings; coordinate with regulatory and audit teams.

Skills

Deviation management

CAPA

Quality systems

Root cause analysis

Inspection readiness

Cross-functional collaboration

Regulatory inspections

Risk-based thinking

Education

Bachelor's degree in Engineering, Pharmacy, Biology, Chemistry, Chemical Engineering, or Life Sciences

Job description

GSK at the Marietta site is seeking a Deviation Local Process Owner to oversee deviation and CAPA systems in vaccine manufacturing. The role ensures adherence to Quality Systems procedures, drives KPI development, trend analysis, and corrective actions, and maintains inspection readiness across the site.

You will collaborate with quality, manufacturing, regulatory, and cross-functional teams to resolve quality issues, lead investigations, and implement robust preventive actions, aiming to