Senior Director, Site Head of Quality

Senior Director, Site Head of Quality

Position Summary:

100% onsite. Working for Catalent Biologics is an opportunity to join an entrepreneurial team that is investing heavily in people and capabilities. This is a unique opening to join a small, fast‑growing business backed by a private company and offers significant career development opportunities as the business expands.

Partner effectively with other functional leaders (Process Development, Operations, Program Management, etc.) and the Site General Manager to develop and maintain a meaningful and robust Patient First and Quality culture across all aspects of the business. Champion Catalent’s Quality Management System (QMS) and ensure strong technical and leadership capability at all levels of the Quality organization. Oversee the site Quality teams (100‑200 HC), ensuring they are staffed with high‑caliber leaders and professionals, driving a performance culture and a succession pipeline for key leadership roles.

Define activity‑based cost models, establish and execute a budget aligned with business requirements to deliver testing, release, and QMS effectiveness. Ensure appropriate metrics, reporting, and escalation processes are in place to drive operational execution and improve quality performance. Lead corrective actions and CAPA plans, review and approve critical deviations, and drive remediation actions to meet quality standards.

• Bachelor’s or Master’s Degree in science, pharmacy, or a related discipline.
• Extensive experience (10+ years) in biologics, including drug substance manufacturing (required) and drug product manufacturing (preferred).
• Demonstrated business acumen and ability to manage difficult discussions with clients.
• Successful experience leading Quality organizations, preferably in a matrix‑style environment.
• Knowledge of global cGMP regulations (FDA, EMA, ANVISA, and other Tier‑1 regulatory agencies).
• Proven track record in driving substantial improvements of quality performance through talent development, process improvements, and SOP standardization.
• Strong regulatory guidance interpretation skills and capability to defend positions to regulatory agencies.
• Leadership experience at Catalent (e.g., participation in NGGL, GOLD, LEAD Now, GM Excellence, GROW) may be considered in place of external experience.

• Defined career path with annual performance reviews and feedback.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• Dynamic, fast‑paced work environment.
• Community engagement and green initiatives.
• Generous 401(k) match and paid time off accrual.
• Medical, dental, and vision benefits effective day one of employment.

Catalent is an Equal Opportunity Employer, including disability and veterans.