Associate Director, Regulatory Compliance and Quality Systems

Overview Shift: Monday‑Friday 8:00am‑5:00pm, 100% on‑site. The role is based at Catalent’s Kansas City facility—a leading center for integrated development, manufacturing, and packaging of oral solid dosage forms. The Associate Director will lead the strategy and processes required to maintain regulatory compliance, audit readiness, and quality systems across the site. Responsibilities Lead Regulatory Compliance, Quality Systems, Training, and Quality Audits functions to ensure site‑wide compliance. Provide strategic oversight of quality systems including audits, supplier management, document control, and training. Own and drive the Audit Ready 365 program, including inspection readiness and response management. Support regulatory filings, Quality Technical Agreements, and client documentation. Ensure compliance with cGMPs, regulatory requirements, and corporate quality standards. Oversee regulatory activities including site licensure, drug listings, and audit responses. Manage and develop leadership teams, including performance management and staffing strategy. Drive continuous improvement initiatives across quality and compliance programs. Qualifications Associate’s degree with 20+ years of Scientific or Quality Assurance experience,ORBachelor’s degree with 10+ years of Scientific or Quality Assurance experience. Strong knowledge of cGMP regulations and pharmaceutical compliance requirements. Experience leading regulatory compliance, quality systems, and audit programs. Experience supporting regulatory inspections, filings, and Quality Technical Agreements (QTAs). Experience managing quality systems (e.g., audits, supplier management, training, document/change control). Leadership experience managing teams and developing managers. Strong communication, problem‑solving, and decision‑making skills. Ability to work under pressure and meet deadlines. Ability to drive continuous improvement and identify gaps in compliance systems. Benefits Competitive medical benefits and 401(k). 152 hours PTO + 8 paid holidays. Dynamic, fast‑paced work environment. Opportunity to work on continuous improvement processes. Equal Opportunity Employer Catalent is an Equal Opportunity Employer, including disability and veterans. #J-18808-Ljbffr Catalent Pharma Solutions