Director of Quality

BioTalent; Augusta (GA); On-site; USD 180,000 - 240,000; Full time

Job summary

BioTalent is seeking a Director of Quality to lead the site’s QA and QC functions in a biologics/pharmaceutical manufacturing setting. The role will drive the QMS, batch disposition, product release, and continuous improvement across the site, ensuring global regulatory and cGMP compliance.

The ideal candidate will have 15+ years in pharma/biotech, strong experience with FDA inspections, and a track record of building high-performing quality teams within a CDMO environment.

Qualifications

• 15+ years of experience in pharmaceutical, biotech, or related regulated industries.
• Significant Quality Operations leadership experience in a CDMO environment.
• Strong background supporting FDA and international regulatory inspections.
• Expertise in Quality Systems, cGMP compliance, validation, CAPA, risk management, and product release activities.
• Experience leading quality teams in a manufacturing environment.

Responsibilities

• Lead site-wide Quality Assurance and Quality Control operations.
• Oversee and continuously improve the Quality Management System (QMS).
• Serve as the primary quality contact during customer audits and regulatory inspections.
• Drive inspection readiness programs and support interactions with FDA and other global health authorities.
• Ensure compliance with cGMP, ICH guidelines, and corporate quality standards.
• Provide leadership for batch disposition and product release activities.
• Review and approve quality agreements, validation activities, investigations, CAPAs, deviations, and change controls.
• Partner cross-functionally with Manufacturing, Technical Operations, Regulatory, and Development teams.
• Support regulatory filing activities, including CMC documentation and lifecycle management initiatives.
• Build, mentor, and develop a high-performing quality organization.
• Lead quality risk management and continuous improvement initiatives across the site.

Skills

Quality Leadership

Regulatory Inspections (FDA & intl)

cGMP Compliance

Quality Systems & CAPA

Education

BS in Chemistry / Life Sciences or related

Advanced degree preferred

Job description

We're partnering with a growing pharmaceutical manufacturing organization seeking a Director of Quality to lead site Quality Assurance and Quality Control functions.

This individual will be responsible for maintaining and continuously improving the site's Quality Management System while ensuring the development, manufacture, testing, and release of clinical and commercial pharmaceutical products meets global regulatory and cGMP requirements.

Key Responsibilities

• Lead site-wide Quality Assurance and Quality Control operations.
• Oversee and continually improve the Quality Management System (QMS).
• Serve as the primary quality contact during customer audits and regulatory inspections.
• Drive inspection readiness programs and support interactions with FDA and other global health authorities.
• Ensure compliance with cGMP, ICH guidelines, and corporate quality standards.
• Provide leadership for batch disposition and product release activities.
• Review and approve quality agreements, validation activities, investigations, CAPAs, deviations, and change controls.
• Partner cross-functionally with Manufacturing, Technical Operations, Regulatory, and Development teams.
• Support regulatory filing activities, including CMC documentation and lifecycle management initiatives.
• Build, mentor, and develop a high-performing quality organization.
• Lead quality risk management and continuous improvement initiatives across the site.

Qualifications

• BS in Chemistry, Life Sciences, or a related scientific discipline; advanced degree preferred.
• 15+ years of experience within pharmaceutical, biotech, or related regulated industries.
• Significant Quality Operations leadership experience within a CDMO environment.
• Strong background supporting FDA and international regulatory inspections.
• Expertise in Quality Systems, cGMP compliance, validation, CAPA, risk management, and product release activities.
• Experience leading quality teams in a manufacturing environment.