Director, Quality

About Site

Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent’s cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium. The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production.

Position Summary

We have an opportunity for a Director, Quality to join our team. In this role, you will set the strategic direction for quality, ensure proper staffing, and maintain the Quality Management System to meet regulatory, corporate, and customer requirements. You will lead site metrics, management reviews, and foster a Patient First culture. This position oversees Quality Assurance and Quality Control and serves as the most responsible person for batch disposition. You will also provide project guidance and work with customers to resolve quality concerns.

The Role

• Lead the site Quality function and Quality Management System to ensure compliance with regulatory, corporate, and customer requirements.
• Develop quality strategy, staffing plans, site quality metrics, and management reviews while fostering a patient-first culture.
• Oversee Quality Assurance and Quality Control and act as the site’s most responsible person for batch disposition.
• Partner with customers and internal teams to resolve quality issues and serve as a member of the Site Leadership Team.
• Maintain regulatory and customer compliance across the site.
• Manage audits, inspections, and remediation activities successfully.
• Establish and track site quality metrics and Quality Unit objectives.
• Develop and execute the site Quality Plan and Quality Unit objectives.
• Maintain and improve the Quality Management System.
• Lead, develop, and manage Quality Assurance and Quality Control teams.
• Serve as primary contact for customers and regulatory agencies.
• Review and approve materials, products, batch records, and quality documentation.
• Manage audits, supplier oversight, training programs, and departmental budget.

Candidate Minimum Requirements

• Bachelor’s degree in chemistry, engineering, natural sciences, or related field.
• 10–12 years of pharmaceutical industry experience, including leadership roles.
• Extensive knowledge of Quality Assurance and Quality Control.
• Strong knowledge of current Good Manufacturing Practices (cGMP), International Council for Harmonisation (ICH), and global quality regulations.
• Proven leadership of large, multi-level or multi-shift organizations.
• Able to manage multiple priorities and deliver results on time.
• Able to solve problems and work independently with minimal supervision.
• Strong written, verbal, presentation, and organizational skills.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Preferred Skills & Background

• Experience with sterile drug product manufacturing.
• Experience with drug substance manufacturing.
• Experience with Cell Therapy.
• Experience leading manufacturing site operations.
• Ability to work effectively in a start-up environment.
• Comfortable making decisions in ambiguous situations.
• Experience interacting with regulatory agencies and customers.
• Experience managing regulatory and customer audits.
• Experience with quality systems, validation, and supplier oversight.
• Ability to drive quality-related projects through completion.