Position Summary
The Manager, Quality Assurance is accountable for the performance and compliance of assigned quality systems and operational areas within a regulated contract manufacturing environment. This position provides final quality review and disposition decisions for raw materials, in-process materials, and finished goods, ensuring products meet established specifications, regulatory requirements, and customer expectations.
This role operates with a high degree of autonomy and decision-making authority, serving as a primary Quality leader for the site. The Manager, Quality Assurance is responsible for ensuring effective implementation of cGMP requirements (21 CFR Parts 210/211), maintaining inspection readiness, and supporting a proactive quality culture focused on risk mitigation and continuous improvement.
The position serves as a primary Quality representative for contract manufacturing customers, owning quality communications, documentation, and audit readiness.
Key Responsibilities
Quality System Ownership & Decision Authority
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Own and maintain assigned quality systems, including but not limited to deviations, investigations (OOS/OOT), CAPA, change control, batch record review, and product disposition
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Provide final quality review and release/disposition decisions for materials and finished products
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Exercise independent decision-making authority for routine and non-routine quality events, ensuring compliance with cGMP and customer requirements
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Escalate significant quality risks (e.g., recall risk, critical events) in accordance with established procedures
Manufacturing Quality Oversight
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Provide QA oversight of liquid fill manufacturing operations to ensure compliance with cGMPs, internal procedures, and customer-specific requirements
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Support real-time decision-making on the production floor related to deviations, non-conforming materials, and process issues
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Ensure effective execution of in-process controls and finished product inspection requirements
Contract Manufacturing Quality Leadership
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Serve as the primary Quality representative for assigned contract manufacturing customers
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Lead customer quality discussions, governance meetings, and issue resolution calls independently
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Own all customer quality communications, including:
- Deviations and investigations
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Complaint responses
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Customer notifications and regulatory commitments
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Prepare and review customer-specific documentation, including:
- Questionnaires and technical requests
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Specifications and supporting quality data
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Audit responses and follow-up documentation
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Lead and/or support customer audits, ensuring transparency, professionalism, and inspection readiness
Compliance & Regulatory Oversight
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Ensure compliance with applicable regulatory requirements, including FDA, EPA, DNR, ATF, and OSHA
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Maintain inspection readiness at all times; support and lead regulatory inspections and customer audits
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Ensure adherence to data integrity principles (ALCOA+) across all quality systems and documentation
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Ensure consistent and compliant application of site procedures and quality standards
Investigation & Risk Management
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Lead and approve investigations, including OOS, OOT, deviations, and nonconformances
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Ensure robust root cause analysis and implementation of effective corrective and preventive actions
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Monitor and trend quality data to identify emerging risks and drive proactive improvements
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Apply risk-based decision making consistent with ICH Q9 principles
Validation & Change Control Oversight
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Ensure validation programs comply with regulatory requirements and internal procedures
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Oversee quality impact assessments and approvals within the change control system
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Ensure appropriate evaluation of changes for regulatory, product quality, and customer impact
Leadership & Personnel Management
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Directly supervise and develop quality personnel, including both hourly and salaried employees
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Ensure effective training, qualification, and ongoing development of staff
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Provide performance management, coaching, and leadership to drive a high-performing quality organization
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Foster a culture of accountability, ownership, and continuous improvement
Operational Support & Continuous Improvement
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Partner cross-functionally with Manufacturing, Supply Chain, Engineering, and R&D to resolve quality issues and improve performance
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Drive continuous improvement initiatives to enhance product quality, reduce variability, and improve efficiency
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Support site quality metrics and ensure alignment with business and customer expectations
Qualifications
Education
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Bachelor’s degree in Chemistry, Microbiology, Engineering, or related scientific discipline required
Experience
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Minimum 10 years of experience in a regulated industry (OTC drug, pharmaceutical, cosmetic, or similar)
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Minimum 5 years of progressive leadership experience in Quality Assurance or Quality Systems
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Demonstrated experience supporting FDA inspections and customer audits
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Experience in a contract manufacturing environment strongly preferred
Knowledge, Skills, and Abilities
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Strong knowledge of cGMP requirements (21 CFR Parts 210/211) and quality system expectations
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Demonstrated ability to make independent, risk-based quality decisions
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Strong investigation skills, including root cause analysis and CAPA effectiveness
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Excellent technical writing and documentation skills
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Strong communication skills with the ability to interface effectively with customers and all levels of the organization
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Ability to manage multiple priorities in a fast-paced manufacturing environment
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High level of accountability, ownership, and professional judgment
Work Environment
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Work is performed in a combination of office, laboratory-adjacent, and manufacturing environments
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Regular exposure to production areas with varying temperatures, noise levels, and proximity to operating equipment
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Required use of appropriate personal protective equipment (PPE)
Physical Demands
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Regularly required to stand, walk, use hands, and communicate effectively
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Frequently required to move throughout manufacturing and warehouse areas
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Occasional lifting of materials up to 40–50 pounds; frequent handling of light samples (1–5 pounds)
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Requires visual acuity for detailed review of documentation and inspection activities, including ability to distinguish color and fine detail
