Deviation Investigation Supervisor

Lonza • Portsmouth, NH

18h • Onsite

About The Position

As a Deviation Investigation Supervisor, you will lead a team of investigators (Level I through Senior II), drive the timely, high-quality completion of deviation investigations while fostering a culture of compliance, accountability, and continuous improvement. You will play a critical leadership role in aligning team performance with departmental and site goals, ensuring adherence to cGMP standards and regulatory expectations.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field (advanced degree preferred)
• 6–8+ years of experience in a GMP-regulated environment within Quality Assurance, Quality Systems, or similar
• Prior experience leading, supervising, or mentoring teams, with demonstrated ability to drive performance and accountability
• Strong knowledge of cGMP regulations (FDA, EMA, ICH) and Quality Risk Management principles (ICH Q9)
• Experience conducting risk assessments using tools such as FMEA, HACCP, Fishbone, and What-if analysis
• Proven ability to drive compliant, inspection-ready investigation and risk management solutions
• Strong analytical and problem-solving skills with a data-driven approach
• Experience developing and delivering technical training to support team growth and performance
• Excellent communication and stakeholder management skills across all levels of the organization

Responsibilities

• Lead and develop a team of deviation investigators (Level I through Senior II), ensuring high-quality, timely completion of investigations
• Assign and manage team workload, aligning resources with business priorities and investigator experience levels
• Provide technical guidance, problem-solving support, and escalation management for complex investigations
• Ensure full compliance with cGMPs, SOPs, and regulatory expectations while promoting a strong quality mindset
• Monitor performance through metrics and KPIs, driving continuous improvement in quality, efficiency, and cycle time
• Partner cross-functionally with Manufacturing, Quality, and other stakeholders to support investigations and deviation reduction
• Facilitate key meetings, including daily management system (DMS), deviation review boards, and cross-functional discussions
• Coach, mentor, and develop employees through 1:1s, performance reviews, and career development planning
• Lead or support projects to improve deviation processes and provide coverage for the Deviation Investigations Manager as needed

Benefits

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level