Manager, Audits & Inspections - Quality Systems & Compliance

Thermo Fisher Scientific seeks a Manager for Audits & Inspections to oversee quality compliance programs, manage internal and external audits, and ensure regulatory inspection readiness. The role leads cross-functional teams and coordinates with health authorities including FDA and EMA.

Responsibilities

• Oversee external client audit scheduling, execution, and serve as primary contact
• Plan and execute mock and regulatory inspections with FDA, EMA, ANVISA, MHRA
• Coordinate corrective and preventive action reviews and implementation tracking
• Lead, mentor, and develop audit and inspection personnel on quality compliance
• Ensure documentation and record retention standards support audit and inspection requirements

Requirements

• Bachelor's degree in science, information management, engineering, or related field
• At least 5 years of supervisory or managerial experience with direct reports
• At least 7 years in pharmaceutical or medical device industry
• At least 5 years in quality assurance or quality systems roles
• Strong knowledge of 21 CFR Parts 210/211/600/820, ISO 13485/9001, ICH Q9/Q10
• Proficiency with electronic quality management systems (Documentum, Veeva Vault, TrackWise)
• Excellent cross-functional communication and problem-solving abilities