Description:
The Manager – Quality Management Systems & Compliance is responsible for end-to-end ownership of the Quality Management System (QMS) at an Oral Solid Dosage manufacturing site. This role ensures sustained compliance with global regulatory requirements (FDA, EMA, MHRA, ICH) and drives continuous improvement through robust risk management, and data-driven quality oversight. The position requires strong leadership in managing planned/unplanned deviations, CAPA, change controls, and audit readiness, while partnering cross-functionally to ensure product quality and regulatory compliance. The Manager, Quality Systems may also manage other quality assurance professional staff, and/or quality assurance programs and projects, and interfaces with both internal and external senior managers in operations and QA to ensure full compliance with FDA GMP standards and regulations. Influencing stakeholders and partners, and effectively recommending solution/options to complex quality assurance issues is required.
Essential Functions:
- Own and manage site QMS elements including Change Control, Deviations, CAPA, OOS, Complaints ensuring timely closure and compliance with cGMP
- Lead and approve complex investigations ensuring scientifically justified root cause analysis and implementation of effective CAPAs
- Ensure continuous audit readiness; act as SME during regulatory inspections and customer audits; lead response preparation and closure
- Establish and monitor quality metrics; perform trend analysis for deviations, CAPA, complaints, and OOS to drive continuous improvement
- Implement Quality Risk Management (ICH Q9) across QMS processes and product lifecycle
- Oversee quality compliance during new product introduction (NPI), validation, and commercialization activities
- Establishes statistical reliability by using mean time before failure, reliability modeling, and reliability demonstration tests, or by any other statistical tools.
- Act as SME for electronic QMS systems (Caliber,ValGenesis, SAP, etc.) and drive digitalization initiatives
- Prepares reports by collecting, analyzing, and summarizing data; making recommendations.
- Collaborate with cross-functional teams (Manufacturing, QC, Validation, Supply Chain) to resolve quality issues and ensure compliance
Additional Responsibilities:
- Participates in FDA inspections as required. Support internal audits and self-inspection programs
- Support QM Director with interaction with regulators during site inspections relative to GMP facility areas and equipment; support successful management of inspections
- Support quality assurance efforts for GMP related facility and equipment systems to ensure full GMP compliance. Ensure commitments to regulatory agencies are tracked and met
- Train and develop QA and other Operations staff in relevant technical subjects, and is a key contributor to GMP training activities
- Review and approve SOPs, protocols, reports, and quality documentation
- Drive continuous improvement initiatives aligned with corporate quality strategy
- Perform other duties as assigned
