Director, Quality

Director, Quality

Position Summary 

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. 

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Director of Quality. The Director of Quality leads the quality unit at the site and is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to assure the site is compliant with regulatory (21 CFR Parts 4, 201, 211, and 820), Corporate, and customer requirements. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality is responsible for providing project guidance and support and work with customers to resolve quality concerns as appropriate. They will be responsible for operational and compliance performance across regulatory authorities and markets while meeting expectations necessary to drive growth and customer satisfaction.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 

The Role 

• Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit ensuring expectations are met consistently and at a high level. Ensures the site meets requirements for drug and combination product manufacturing across product technologies including Biologics and Analytical Services.

• Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.

• Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.

• Monitor site compliance to FDA, EU and all other applicable requirements.

• Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated.

• Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner.

• Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records.

• Ensure that all necessary QC testing is performed on manufactured products supporting and meeting business objectives and on-time deliveries. Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures.

• Other duties as assigned.

The Candidate 

• Bachelor's Degree Required (scientific field preferred). Master's Degree in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology preferred.

• 10+ years’ experience in pharmaceutical industry with increasing levels of responsibility and leadership in quality assurance, compliance and quality control.

• Experience leading Quality Operations at a manufacturing site operation for 3 years at a minimum (e.g. Quality Operations, QC Operations, Manufacturing) is required.

• Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment

• Must have a demonstrable record of implementing and maintaining a total quality system; laying out a strategic plan and overseeing the tactical implementation