Sr. Manager Quality Systems & Compliance

About the role

The Manager, Quality Systems is responsible for overall management of Quality Systems at the site. The incumbent ensures that Quality Assurance (QA) activities are conducted in compliance with Current Good Manufacturing Practices (cGMP) and that all SOPs and applicable regulations are followed. This position supports internal and external audits, regulatory inspections, and the continuous improvement of quality processes.

Key Accountabilities

• Support internal and external audits and regulatory inspections; conduct audits, inspections, and walkthroughs; ensure corrective actions are implemented; represent quality systems during audits; participate in audit responses; maintain QA retain inventory and perform annual retain inspections.
• Prepare or review Annual Product Reviews, Non‑Conforming Material Reports, Investigation Reports, and validation documentation.
• Oversee CAPAs, document reviews, environmental monitoring, quality metrics, quality agreements, TrackWise events, deviations, OOS/OOT investigations, procedure maintenance, and gap assessments.
• Perform routine and ad‑hoc quality systems reporting, trend analysis, and management review support.
• Participate in risk management activities and maintain appropriate risk documentation.
• Manage the QA Systems team, training activities, training records, and training module development.

Education / Experience

• Bachelor’s degree in the physical or biological sciences or engineering (Chemistry/Chemical Engineering preferred).
• Minimum ten (10) years experience in pharmaceutical operations, regulated life sciences, or quality assurance, with 2‑5 years supervisory experience.
• Minimum five (5) years experience in QA leadership.
• Knowledge of GMP requirements (21 CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
• Strong computer skills with Microsoft Office, databases, reporting and statistical tools.
• Proficiency in TrackWise, SAP, and MasterControl.

Job Competencies

• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Strong analytical skills and ability to work independently against multiple deadlines.
• Experience interacting with FDA or other regulatory agencies.
• Knowledge of manufacturing quality, validation, SPC, facilities, and critical systems.
• Must complete tasks independently and notify supervisor of decisions outside established processes.

Physical Demands and Work Environment

Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions. The role may involve frequent lifting, bending, stooping, squatting, pushing, and pulling, as well as long periods of sitting, walking, typing, and computer work. Potential limited exposure to hazardous chemicals is possible. Personal protective equipment—including safety glasses, lab coats, gloves, specialized clothing, and appropriate shoes—may be required.