Associate Director, Quality BioAnalytical

Associate Director, Quality - BioAnalytical

• Position Summary
• + •

Shift:

• Monday - Friday 8am-5pm + 100% on-site Catalent, Inc.

is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The

• Associate Director
• ,•Quality - BioAnalytical•will lead key Quality functions within our Biologics Analytical Services (BAS) group in Kansas City, MO.

This leader will oversee teams responsible for ensuring high-quality analytical testing, data integrity, and compliance across biologics programs. The role combines people leadership, quality oversight, customer interaction, and continuous improvement within a fast‑growing biologics environment.

• The role:
• + Responsible for all activities within one or more functional areas.

+ Responsible for management of department Capex. + Identify and support implementation of new technologies within the BAS Quality Department. + Ensure employee training is executed according to defined training plans and maintain current training plans. + Identify, maintain, and report functional KPIs to site management. + Monitor and report project milestone completion and timing. + Drive continuous improvement through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and KPI performance improvements.

• The candidate:
• + Doctorate Degree in STEM discipline with minimum of 6 years related experience + Master's Degree in STEM discipline with minimum of 10 years related experience + Bachelor's Degree in STEM discipline with minimum of 12 years related experience + Leadership experience minimum of 5 years.

+ Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred. + Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution. + Experienced in most aspects of drug development and life cycle support, and able to develop useful strategies and tactics to meet regulatory milestones.

• 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 (https://careers.catalent.com/us/en) 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 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. 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. Important Security Notice to U.S.

Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .