Quality Assurance Manager

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Killingly, CT, US

11 days ago Requisition

Salary Range: $85,000.00 To $ Annually

August 31, 2026

The Quality Assurance Manager is responsible for leading the Quality Assurance function and maintaining independent oversight of product quality, compliance, and product disposition activities within a regulated manufacturing environment supporting active pharmaceutical ingredients (APIs) and cosmetic ingredients.

This position serves as the primary Quality Assurance authority for final product release and other designated quality decisions and works closely with Quality Systems, Quality Control, Operations, Technical Services, Regulatory Affairs, Maintenance/Facilities, Supply Chain, and senior management to ensure the continued effectiveness of the Quality Management System.

The Quality Assurance Manager is expected to provide Quality oversight while supporting timely, scientifically justified decision-making and continuous improvement. The role requires strong judgment, leadership capability, and the ability to balance regulatory expectations with practical manufacturing and business considerations.

• Lead the day-to-day activities of the Quality Assurance department and provide direction, coaching, and development to Quality Assurance personnel.
• Maintain independent Quality Assurance authority for final product disposition and release
  , including the authority to withhold or reject product when applicable quality, compliance, documentation, or release requirements have not been satisfied.
• Review and approve, as applicable,
  deviations, investigations, CAPAs, change controls, OOS/OOT investigations, complaints, validation documentation, risk assessments, planned deviations, and other Quality Management System records
  .
• Ensure that departments remain accountable for investigations, CAPAs, change controls, training, documentation, and other QMS responsibilities within their areas of ownership while providing appropriate QA oversight and review.
• Monitor and support achievement of key Quality performance indicators, including investigation and deviation timeliness, CAPA completion, documentation compliance, customer complaints, product loss, training completion, and other established Quality metrics.
• Support and maintain compliance with applicable FDA regulations, current Good Manufacturing Practices (cGMP), pharmaceutical/API requirements, cosmetic requirements, customer requirements, and internal Quality standards
  .
• Maintain working knowledge of applicable 21 CFR requirements
  , ICH guidance applicable to API manufacturing, and relevant U.S. and international regulatory expectations.
• Support compliance with applicable international cosmetic and pharmaceutical ingredient requirements and customer-specific quality standards.
• Serve as a key Quality representative during FDA inspections, customer audits, supplier audits, certification audits, and internal or affiliate Quality assessments
  , including preparation of documentation, presentation of Quality System information, and follow-up on audit observations.
• Support inspection readiness by ensuring Quality records are complete, accurate, traceable, current, and readily retrievable.
• Oversee and support product release documentation, batch record review, Certificates of Analysis/Conformance where applicable, and related Quality documentation.
• Ensure appropriate management of controlled documents, procedures, forms, specifications, training records, and Quality records in accordance with established document-control requirements.
• Participate in the review and approval of validation and qualification activities, including process validation, cleaning validation, equipment qualification, manufacturing scale-up, and changes affecting validated processes.
• Provide Quality input for new product introductions, process changes, equipment changes, raw-material changes, supplier changes, and commercialization activities.
• Participate in Quality risk assessments and ensure decisions are appropriately based on product risk, regulatory risk, scientific evidence, process understanding, historical performance, and documented rationale.
• Support supplier and contract-manufacturer qualification activities, customer complaints, nonconforming material…