Associate Director, Regulatory Compliance and Quality Systems
Position Summary
Shift: Monday - Friday 8:00am - 5:00pm
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.
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
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
Qualifications
- 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
Skills
- 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 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
Pay
- Commensurate with experience
Schedule
- Monday - Friday 8:00am - 5:00pm
Contact
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 DisabilityAccommodations@catalent.com. 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.