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.

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:

• 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 Tea; .
• 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:

• Bachelor’s Degree in Chemistry or closely related field (e.g. natural sciences, engineering) is strongly preferred;
• Eight (8) years’ directly related experience in pharmaceutical fields including managerial roles;
• Experience with sterile and blood drug product development, manufacturing and testing is strongly preferred;
• Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred;
• Must have a demonstrable record of implementing and maintaining and total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics;
• Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards;
• Experience in facilitating regulatory inspections;
• Strong understanding of the functional areas of manufacturing, sourcing, materials management and quality control;
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience;

Why You Should Join Catalent:

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
• Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions.
• Paid Time Off Programs including Vacation, banked time, and personal time.
• Employee Reward and Recognition Programs.
• Opportunities for professional and personal development.

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 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.