MANAGER QUALITY

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

• Own and maintain assigned quality systems, including but not limited to deviations, investigations (OOS/OOT), CAPA, change control, batch record review, and product disposition
• Provide final quality review and release/disposition decisions for materials and finished products
• Exercise independent decision-making authority for routine and non-routine quality events, ensuring compliance with cGMP and customer requirements
• Escalate significant quality risks (e.g., recall risk, critical events) in accordance with established procedures

Manufacturing Quality Oversight

• Provide QA oversight of liquid fill manufacturing operations to ensure compliance with cGMPs, internal procedures, and customer-specific requirements
• Support real-time decision-making on the production floor related to deviations, non-conforming materials, and process issues
• Ensure effective execution of in-process controls and finished product inspection requirements

Contract Manufacturing Quality Leadership

• Serve as the primary Quality representative for assigned contract manufacturing customers
• Lead customer quality discussions, governance meetings, and issue resolution calls independently
• Own all customer quality communications, including:
  • Deviations and investigations
  • Complaint responses
  • Customer notifications and regulatory commitments
• Prepare and review customer-specific documentation, including:
  • Questionnaires and technical requests
  • Specifications and supporting quality data
  • Audit responses and follow-up documentation
• Lead and/or support customer audits, ensuring transparency, professionalism, and inspection readiness

Compliance & Regulatory Oversight

• Ensure compliance with applicable regulatory requirements, including FDA, EPA, DNR, ATF, and OSHA
• Maintain inspection readiness at all times; support and lead regulatory inspections and customer audits
• Ensure adherence to data integrity principles (ALCOA+) across all quality systems and documentation
• Ensure consistent and compliant application of site procedures and quality standards

Investigation & Risk Management

• Lead and approve investigations, including OOS, OOT, deviations, and nonconformances
• Ensure robust root cause analysis and implementation of effective corrective and preventive actions
• Monitor and trend quality data to identify emerging risks and drive proactive improvements
• Apply risk-based decision making consistent with ICH Q9 principles

Validation & Change Control Oversight

• Ensure validation programs comply with regulatory requirements and internal procedures
• Oversee quality impact assessments and approvals within the change control system
• Ensure appropriate evaluation of changes for regulatory, product quality, and customer impact

Leadership & Personnel Management

• Directly supervise and develop quality personnel, including both hourly and salaried employees
• Ensure effective training, qualification, and ongoing development of staff
• Provide performance management, coaching, and leadership to drive a high-performing quality organization
• Foster a culture of accountability, ownership, and continuous improvement

Operational Support & Continuous Improvement

• Partner cross-functionally with Manufacturing, Supply Chain, Engineering, and R&D to resolve quality issues and improve performance
• Drive continuous improvement initiatives to enhance product quality, reduce variability, and improve efficiency
• Support site quality metrics and ensure alignment with business and customer expectations

Qualifications

Education

• Bachelor’s degree in Chemistry, Microbiology, Engineering, or related scientific discipline required

Experience

• Minimum 10 years of experience in a regulated industry (OTC drug, pharmaceutical, cosmetic, or similar)
• Minimum 5 years of progressive leadership experience in Quality Assurance or Quality Systems
• Demonstrated experience supporting FDA inspections and customer audits
• Experience in a contract manufacturing environment strongly preferred

Knowledge, Skills, and Abilities

• Strong knowledge of cGMP requirements (21 CFR Parts 210/211) and quality system expectations
• Demonstrated ability to make independent, risk-based quality decisions
• Strong investigation skills, including root cause analysis and CAPA effectiveness
• Excellent technical writing and documentation skills
• Strong communication skills with the ability to interface effectively with customers and all levels of the organization
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• High level of accountability, ownership, and professional judgment

Work Environment

• Work is performed in a combination of office, laboratory-adjacent, and manufacturing environments
• Regular exposure to production areas with varying temperatures, noise levels, and proximity to operating equipment
• Required use of appropriate personal protective equipment (PPE)

Physical Demands

• Regularly required to stand, walk, use hands, and communicate effectively
• Frequently required to move throughout manufacturing and warehouse areas
• Occasional lifting of materials up to 40–50 pounds; frequent handling of light samples (1–5 pounds)
• Requires visual acuity for detailed review of documentation and inspection activities, including ability to distinguish color and fine detail

Education

• Bachelor’s degree in Chemistry, Microbiology, Engineering, or related scientific discipline required

Experience

• Minimum 10 years of experience in a regulated industry (OTC drug, pharmaceutical, cosmetic, or similar)
• Minimum 5 years of progressive leadership experience in Quality Assurance or Quality Systems
• Demonstrated experience supporting FDA inspections and customer audits
• Experience in a contract manufacturing environment strongly preferred

Knowledge, Skills, and Abilities

• Strong knowledge of cGMP requirements (21 CFR Parts 210/211) and quality system expectations
• Demonstrated ability to make independent, risk-based quality decisions
• Strong investigation skills, including root cause analysis and CAPA effectiveness
• Excellent technical writing and documentation skills
• Strong communication skills with the ability to interface effectively with customers and all levels of the organization
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• High level of accountability, ownership, and professional judgment

Work Environment

• Work is performed in a combination of office, laboratory-adjacent, and manufacturing environments
• Regular exposure to production areas with varying temperatures, noise levels, and proximity to operating equipment
• Required use of appropriate personal protective equipment (PPE)

Physical Demands

• Regularly required to stand, walk, use hands, and communicate effectively
• Frequently required to move throughout manufacturing and warehouse areas
• Occasional lifting of materials up to 40–50 pounds; frequent handling of light samples (1–5 pounds)
• Requires visual acuity for detailed review of documentation and inspection activities, including ability to distinguish color and fine detail