Director of Quality

Director of Quality – Packaging Operations

Industry: Pharmaceutical Manufacturing / CDMO

A leading pharmaceutical manufacturing organization is seeking a Director of Quality – Packaging Operations to provide strategic Quality leadership within a GMP manufacturing environment.

This is a key site leadership role responsible for ensuring quality compliance, operational excellence, and continuous improvement across packaging operations. You will lead Quality systems, oversee investigations and CAPAs, support regulatory inspections, and partner closely with Operations, Technical teams, customers, and regulatory agencies to maintain the highest standards of product quality and compliance.

Key Responsibilities:

• Lead Quality oversight for pharmaceutical packaging operations within a GMP manufacturing facility.
• Own and drive site Quality systems, including deviations, investigations, CAPAs, change controls, and continuous improvement initiatives.
• Provide Quality leadership during regulatory inspections, customer audits, and internal audits.
• Partner cross-functionally with Manufacturing, Engineering, Validation, and Technical Operations teams to ensure compliance and operational performance.
• Develop and mentor a high-performing Quality team, fostering a culture of accountability and continuous improvement.
• Support validation activities, regulatory requirements, and quality strategies for packaging operations.
• Act as a key Quality partner for internal stakeholders and external customers.

Qualifications &

Experience:

• Extensive experience leading Quality functions within pharmaceutical manufacturing environments.
• Strong background in packaging operations, ideally within sterile manufacturing, fill-finish, or CDMO environments.
• Proven experience with GMP regulations, regulatory inspections, customer audits, deviations, CAPAs, and quality systems.
• Experience leading and developing Quality teams within a complex manufacturing environment.
• Strong understanding of validation, compliance, and pharmaceutical quality requirements.
• Excellent communication and leadership skills with the ability to influence cross-functional teams.

This is an excellent opportunity for an experienced Quality leader to take ownership of a critical site function within a growing pharmaceutical manufacturing organization.