Director, Quality BioAnalytical

Director, Quality, BioAnalytical

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 Clinical Delivery Services and Biologics Analytical 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 is hiring a Director of Quality who is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to assure the site / division is compliant with regulatory, 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 at the site / division is the most responsible person for Quality. The Director of Quality is responsible for providing project guidance and support and work with customers to resolve quality concerns as appropriate. The Quality Director is the business partner to Operations and advisor to the General Manager of the site.

Location : Kansas City, MO on-site position.

The Role :

• Has functional responsibility for QA and QC and strategic responsibility as part of the Quality Leadership Team for BioAnalytical. Leadership of Our large molecule analytical team has over 25 years of experience;
• Reporting to the VP, Quality, Biologics and sits on the extended Quality Leadership Team supporting the strategic direction on the BioAnalytical Business Unit;
• Part of the global Catalent Leadership Team;
• Initially responsible for oversight of the build out of the facilities, systems, and processes for BioAnalytical and the establishment of a high-performing quality team and integration of the QMS into Catalent;
• Continuously improve the agility, flexibility, speed, accuracy, and compliance of BioAnalytical performance by embedding the Catalent Way, as to how we do business and operate day to day;
• Responsible for guiding the site / division for inspection readiness;
• Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site Quality Plan, Quality Unit objectives and focused on ensuring specific focus upon best-in-class Quality Control related procedures;
• Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements / expectations, with particular focus upon Analytical and Quality Control;
• Ensure the QMS is agile and flexible to accommodate a diverse portfolio of service offerings consisting of a broad-based and orthogonal analytical CMC services for stand-alone and integrated biologics projects. E.g. analytical support for drug substance, drug product, and intermediates for both innovator and biosimilar / bio better products;
• Interface with all other departments to ensure compliance with cGMP and excellence in customer service.
• Monitor site compliance to FDA, EU, and all other applicable requirements and ensure site procedures align with Corporate policies;
• Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated;
• Analyze, resolve, or assist in solving compliance and customer issues;
• Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner;

The Candidate :

Why You Should Join Catalent :

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.