Quality Assurance Operations Manager

The Quality Assurance Operations Manager is responsible for leading and overseeing all quality assurance activities within a regulated manufacturing environment. This individual ensures products are manufactured, tested, and released in full compliance with applicable regulatory requirements, cGMP standards, internal procedures, and site quality objectives.

This role provides both strategic and hands-on leadership for QA functions and plays a critical role in maintaining product quality, supporting inspection readiness, and driving continuous improvement across the site. The position reports to senior site quality leadership.

Key Responsibilities

• Lead daily Quality Assurance operations, including In-Process QA (IPQA) and Raw Materials QA, ensuring compliance with regulatory and internal quality standards.
• Oversee batch record review and final product disposition, ensuring accurate and timely release of finished goods.
• Provide real-time quality oversight on the manufacturing floor, supporting GMP operations and ensuring adherence to procedures.
• Lead internal audits, customer audits, and regulatory inspections, including preparation and follow-up activities.
• Review and approve investigations related to deviations, non-conformances, and atypical events, ensuring thorough root cause analysis and effective CAPA implementation.
• Ensure execution of quality programs such as incoming material inspection, acceptance quality limits, and first article inspections, as applicable.
• Partner cross-functionally with Manufacturing, Quality Control, R&D, Maintenance, Regulatory, and Supply Chain to ensure quality is embedded in all processes.
• Author, review, and approve SOPs and controlled documentation to ensure compliance and clarity.
• Develop, coach, and mentor QA team members, fostering a strong culture of quality and accountability.
• Monitor site quality performance through KPIs, trend analysis, and risk assessments to drive continuous improvement.
• Maintain current knowledge of regulatory expectations and industry best practices.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field.
• Experience in Quality Assurance within a GMP-regulated manufacturing environment (pharmaceutical, medical device, or related).
• Strong knowledge of FDA, EMA, and ICH regulatory requirements.
• Hands-on experience with batch review, product release, deviations, investigations, and CAPA management.
• Proven leadership experience managing or developing QA teams.
• Strong communication, problem-solving, and cross-functional collaboration skills.