Senior Manager, Deviation Management – Quality Assurance

Key Responsibilities

• Owes deviation management governance to ensure deviations are triaged, investigated, and closed in a timely, compliant, and high-quality manner.
• Establishes standards for investigation rigor, root cause analysis, impact assessment, and linkage to CAPA and change control.
• Drives performance management (cycle time, backlog, aging) and trending to reduce recurrence and protect compliance and supply.
• Maintains inspection readiness through consistent documentation practices and governance routines across internal and external partners as applicable.
• Coaches teams on investigation quality expectations and effective prevention actions.

Required Qualifications

• BS+ in Science / Engineering (or related)
• 7–10 years in GMP QA / QMS with strong deviation / investigation leadership experience
• Demonstrated improvements in cycle time, investigation quality, and recurrence reduction

Preferred Qualifications

• Experience in pharmaceutical / biotech external manufacturing networks and partner deviation governance (preferred)
• Experience with eQMS workflows and continuous improvement / problem-solving facilitation