Deviation Investigation SupervisorLocation: This position is based in our
Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM-5:00 PM EST.
What you will get: Below you will find a comprehensive summary of the benefits package we offer:
- 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).
Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.
What you will do:
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.
- 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
What we are looking for:
- 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
Ready to shape the future of life sciences? Apply now.
