Associate Director, Regulatory Compliance and Quality Systems

Catalent•Kansas City, MO

3d•Onsite

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