Senior Director, Quality

Overview Senior Director, Quality – 100% on‑site at Catalent’s Kansas City facility. The site is a Center‑of‑Excellence for oral solid dosage forms, biologics analytical services, and clinical supply services. The Senior Director leads the Quality unit for Pharma/Consumer Health (PCH) and the campus, which includes the BioAnalytical Laboratory and the KC Clinical packaging and supply operation. Responsibilities Set strategy and vision for Quality Operations on the Kansas City campus, aligning with General Managers. Ensure sustained compliance with regulatory requirements (21CFR Parts 4,201,211,820, FDA, EU, etc.) and corporate/customer expectations. Build and maintain a robust Quality Management System (QMS) and execute continuous improvement initiatives. Serve as the primary contact for customers and regulatory agencies, managing audits and responding to inquiries. Develop and implement the campus Quality Plan, defining objectives, procedures, and metrics. Approve critical quality inputs such as starting materials, packaging, and batch production records. Ensure proper QC testing, specification approval, and validation activities are completed. Oversee environmental monitoring, storage conditions, and plant hygiene. Lead a multidisciplinary Quality team (often 50+ employees), providing development, coaching, and performance management. Represent the Quality Risk Assessment function on the Site Leadership Team and manage the departmental budget. Qualifications Bachelor of Science required; MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry, or Biology. 10+ years in pharmaceutical or medical device industry with increasing leadership responsibility; 5+ years leading Quality Operations at a manufacturing site. Strong experience with biologics/sterile drug product manufacturing preferred. Demonstrated record of implementing and maintaining a total quality system and strategic quality plans. Proven ability to lead large, multi‑shift, multi‑level teams. Effective risk‑management skills and a Patient‑First mindset. Knowledge of cGMP, ICH, and other non‑US regulations and guidelines; experience applying them in manufacturing and QC labs. Excellent written and verbal communication; ability to present to colleagues and customers. Prior Catalent leadership program participation (NGGL, GOLD, LEAD Now, GM Excellence, GROW) may be considered as equivalent experience. Benefits Defined career path with annual performance reviews and feedback. Diverse, inclusive culture and potential for career growth. Dynamic, fast‑paced work environment with community engagement and green initiatives. Generous 401(k) match and paid time off accrual. Medical, dental, and vision benefits effective day one. Tuition reimbursement. Equal Opportunity Employer Statement Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request by email with the job number, title, and location to View email address on click.appcast.io. #J-18808-Ljbffr