QA Manager

About the role

Reporting to the QA Director, the QA Manager is responsible for leading quality systems and compliance activities to support product delivery and regulatory readiness. This role ensures adherence to cGMP, QSR, GDP, and other applicable standards. The QA Manager oversees quality-related investigations, audits, customer support, and continuous improvement initiatives. The role manages a team of QA Associates and works cross-functionally to resolve quality events and maintain operational excellence.

Role-specific responsibilities

• Ensure ongoing compliance with local, national, and international standards and legislation.
• Lead quality systems and monitoring activities to support product release and regulatory compliance.
• Liaise with customers to manage quality-related requests, corrective actions, and specifications.
• Oversee the quality process related to product shipment and delivery, ensuring timelines and KPIs are met.
• Lead and support internal audits, Health Authority inspections, and customer audits.
• Ensure CAPAs are tracked, implemented, and remediated in a timely manner.
• Manage investigations into batch discrepancies, non-conformances, and out-of-specification events; ensure root cause analysis and corrective actions are completed.
• Ensure product quality complaints are investigated, trended, and resolved in collaboration with relevant departments.
• Monitor quality system performance through KPIs and publish metrics with recommendations for improvement.
• Provide direction to direct reports regarding priorities, trials, audits, new projects, and client visits.
• Develop and implement project management strategies for quality initiatives.
• Achieve results through direct reports by setting goals, coaching, reviewing performance, and supporting development.
• Ensure cross-training of team members to support operations.
• Accomplish financial objectives by forecasting requirements, preparing budgets, analyzing variances, and initiating corrective actions.
• Lead by example and foster collaboration across internal teams and external stakeholders.

Working conditions and physical demands

• Warehouse and production environments; exposure to noise, chemicals, and machinery; PPE required in certain areas.
• Physical demands include walking, standing, and occasional lifting (up to 50 pounds). May require work outside regular hours or weekends.

Competencies required

• Integrity/Personal Credibility: Demonstrated ability and concern that one be perceived as responsible, reliable, and trustworthy.
• Fostering Collaboration/Teamwork: Ability to work jointly with others; as a team leader, demonstrates skill and success in getting groups to learn to work together, builds partnerships for global performance, and respects others.
• Initiative: Identifying what needs to be done and doing it before being asked or before the situation requires it.
• Planning: Organizing the activities required to achieve a desired goal.
• Delegation: Assigning authority and responsibility to another person to carry out specific activities; conveying confidence in their ability to be successful.

Requirements

• 5–7 years of experience in a regulated pharmaceutical industry, including Quality Assurance and Quality Control.
• Minimum 2–3 years in a leadership role.
• BSc degree in a scientific discipline.
• Strong knowledge of cGMP, Quality Systems, Drug Regulatory Affairs, and stability protocols.
• Proven leadership and communication skills across all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.

Preferred: MS degree or MBA.

Benefits

• Health insurance (medical, dental, vision)
• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program