Manager, Production Compliance

Responsibilities

• Lead, manage, and develop a team of Compliance Specialists responsible for deviations, non-conformances, and manufacturing incidents.
• Ensure investigations are completed in a timely manner with appropriate documentation, root cause analysis, and regulatory compliance.
• Serve as SME for investigation.
• Drive consistent use of root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree, etc.).
• Oversee implementation of production CAPAs, inclusive of performing effectiveness checks and follow-up activities.
• Provide regular reporting on deviation trends and metrics to site leadership.
• Identify systemic issues and collaborate with site functions to prevent recurrence.
• Serve as lead liaison with QA, QC, Operations, Engineering, and Supply Chain during investigations.
• Support regulatory inspections and internal audits by providing investigation records and justifications.
• Represent the site's investigation programs, if applicable.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• 7+ years of experience in GMP manufacturing or QA, with at least 3 years in a compliance or investigations role.
• 2+ years of people management or team leadership experience.
• Strong knowledge of FDA regulations, cGMP, and quality systems.
• Experience with TrackWise or similar electronic quality systems preferred.
• Skilled in problem solving, root cause analysis, and CAPA design.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

Physical Requirements

• Combination of office work and time on the aseptic manufacturing floor, including warehouse and support areas.
• Ability to stand, walk, and sit for extended periods, including during floor investigations, line walkthroughs, and audits.
• Ability to bend, stoop, reach, and climb stairs, platforms, or ladders to observe equipment and processes.
• Ability to occasionally lift and carry up to 25 lbs (e.g., batch records, samples, small equipment).
• Ability to qualify for and wear full cleanroom gowning and to follow cleanroom hygiene rules.
• Completion of gowning qualification and ongoing aseptic behavior training.
• Ability to wear required protective equipment (e.g., safety glasses, hearing protection, safety shoes) and work around cleaning and sanitizing agents and moving equipment, following site safety procedures.
• Extended computer, keyboard, and phone use.
• Ability to work extended hours, off-shift, or weekends occasionally to support investigations, audits, or production events.