Senior Quality Director - API CDMO Operations

Hartmann Young Limited; South Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Leadership

QA/QC Leadership

Regulatory compliance

Quality management systems

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Life Sciences

Master's degree preferred

Job description

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