Quality Assurance Manager

August 31, 2026

Quality Manager Roles and Responsibilities 

Position Summary

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.

Key Roles and Responsibilities

• 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 evaluations, and other Quality-related external issues as required.
• Promote a culture of Quality ownership, accountability, collaboration, continuous improvement, and mutual respect throughout the organization.
• Establish clear expectations for Quality performance while maintaining constructive working relationships across Operations, QC, Technical Services, Regulatory Affairs, Maintenance/Facilities, Supply Chain, and other functions.
• Identify opportunities to simplify and improve Quality processes without reducing regulatory compliance, product quality, customer protection, or required Quality oversight.

Education and Experience

Required

• Bachelor of Science degree in Chemistry, Biology, Chemical Engineering, Pharmaceutical Sciences, Quality, or a related scientific or technical discipline.
• Minimum 5–7 years of progressive experience within a regulated Quality environment, preferably within pharmaceutical, API, specialty chemical, cosmetic, personal-care, or similarly regulated manufacturing.
• Working knowledge of FDA regulatory requirements and cGMP expectations, including familiarity with applicable provisions of 21 CFR.
• Previous experience supervising, managing, or developing Quality personnel.

Preferred Experience

• Experience within active pharmaceutical ingredient (API), cosmetic, or cosmetic-ingredient manufacturing or pharmaceutical ingredient manufacturing.
• Familiarity with ICH Q7 and other internationally recognized pharmaceutical Quality standards.
• Familiarity with international cosmetic regulatory requirements and global customer Quality expectations.
• Experience participating in or leading FDA inspections, customer audits, certification audits, or other regulatory assessments.
• Experience working within a manufacturing environment involving process validation, equipment qualification, cleaning validation, and manufacturing scale-up.
• Experience with third-party certification or external compliance programs.
• Experience working in a cross-functional environment involving Operations, QC, Technical Services/R&D, Regulatory Affairs, Supply Chain, and Maintenance/Engineering.

Knowledge, Skills, and Competencies

• Strong working knowledge of Quality Management Systems and regulated manufacturing practices.
• Strong written and verbal communication skills with the ability to clearly document and defend Quality decisions.
• Sound scientific and risk-based decision-making ability.
• Strong leadership, coaching, conflict-resolution, and cross-functional collaboration skills.
• Ability to manage multiple priorities and maintain appropriate Quality oversight in a fast-paced manufacturing environment.
• Strong organizational skills and attention to documentation accuracy and completeness.
• Proficiency with Microsoft Word, Excel, Outlook, and related Microsoft Office applications.
• Experience with electronic Quality Management Systems, ERP systems, and document-management platforms preferred.
• Experience with Sage ERP and/or similar ERP platforms preferred.

Compensation

Salary Range: $85,000–$120,000 per year

Final compensation will be based on relevant education, experience, technical expertise, leadership capability, and overall qualifications.

Benefits and other compensation programs are provided in accordance with company policies.