Associate Director, Regulatory Compliance and Quality Systems
About The Position
Catalent’s Kansas City facility is a leading center for integrated development, manufacturing, and packaging services for oral solid dosage forms. The site combines advanced technologies with a collaborative environment to support pharmaceutical development from early-stage formulation through commercial supply. With a strong focus on quality and innovation, the campus offers modern laboratories, state-of-the-art manufacturing suites, and specialized capabilities to meet diverse client needs. This location fosters teamwork and continuous learning, making it an excellent setting for professionals who want to contribute to delivering life-changing therapies while working in a dynamic and supportive environment. The Associate Director, Regulatory Compliance and Quality Systems is responsible for the strategy and processes required to maintain a state of regulatory compliance at the KCM site through Audit Ready 365, Quality Technical Agreements, support of Client regulatory filings, state licensure, Commercial Data Reports while maintaining oversight of the Quality Systems programs including Supplier Management, Material Review Board, Internal Audits, Client Audits, Training, Document and Change Control, Record Management, Trackwise and other issues and actions as needed.
Requirements
- Associate’s degree with 20+ years of Scientific or Quality Assurance experience, OR Bachelor’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
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 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
Benefits
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Associate degree
