Quality Unit Director

Hartmann Young Limited; South Carolina; Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Hartmann Young Limited is seeking a senior Quality Unit Director to lead QA, QC and the site QMS at one of its US manufacturing facilities. The role focuses on regulatory compliance, continuous improvement, and building a high-performing quality organization to support API development and manufacturing.

The successful candidate will oversee QA/QC operations, manage regulatory inspections, CAPAs and validation activities, and partner with senior leadership on operational excellence and capital

Qualifications

• Bachelor's degree required in Chemistry or Life Sciences; Master's preferred.
• 15+ years of experience in pharmaceutical/biotech manufacturing environments.
• 8+ years of Quality Operations experience within a CDMO.
• Strong API manufacturing experience across clinical and commercial contexts.

Responsabilités

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

Connaissances

Leadership

QA/QC Leadership

Regulatory compliance

Quality management systems

Cross-functional collaboration

Formation

Bachelor's degree in Chemistry/Life Sciences

Master's degree preferred

Description du poste

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