Associate Director, Regulatory Compliance and Quality Systems
Job Description
Associate Director, Regulatory Compliance and Quality Systems
Position Summary
- Shift: Monday - Friday 8:00am - 5:00pm
- 100% on-site
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.
The role:
- 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
The candidate:
- 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
Why you should join Catalent:
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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