Quality Unit Director

Industry: Pharmaceutical CDMO | API Manufacturing

Position: Quality Unit Director

Employment: Full-time | Site-based

The Opportunity

Hartmann Young is partnering with an established pharmaceutical CDMO to appoint a Quality Unit Director at one of its US manufacturing facilities.

This is a senior site leadership position with responsibility for overseeing Quality Assurance (QA), Quality Control (QC) and the site's Quality Management System (QMS), supporting the development and commercial manufacture of Active Pharmaceutical Ingredients (APIs).

The successful candidate will play a key role in maintaining regulatory compliance, driving continuous improvement and developing a high-performing quality organisation.

Key Responsibilities

• Provide strategic and operational leadership across QA and QC functions.
• Lead the development, implementation and continuous improvement of the site's QMS.
• Ensure compliance with FDA, cGMP, 21 CFR and ICH regulatory requirements.
• Lead regulatory inspections, customer audits and site inspection-readiness programmes.
• Oversee quality risk management, deviations, CAPAs and validation activities.
• Manage quality agreements and support customer relationships.
• Oversee the quality release of API intermediates and finished APIs.
• Support regulatory CMC strategies, including Drug Master File (DMF) documentation.
• Develop, mentor and lead quality teams, promoting a strong culture of compliance and accountability.
• Partner with senior site leadership on operational excellence and capital investment initiatives.

Candidate Requirements

• Bachelor's degree in Chemistry, Life Sciences or a related discipline; Master's degree preferred.
• 15+ years of experience within pharmaceutical, biotechnology or related manufacturing environments.
• 8+ years of Quality Operations experience within a CDMO organisation.
• Strong experience in API manufacturing, ideally encompassing clinical and co