Director - Quality Control

Director, Quality Control

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. 

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.

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 

• Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.’

• Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.

• Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.

• Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.

• Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).

• Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.

• Drives systemic process changes as a result of Deviations/Complaints and other quality trends.

• Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.

• Other duties as assigned.

The Candidate 

• Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.

• 6+ years of leadership experience required.

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.

• Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.

• Ability to communicate complex technical information to non-technical audiences.

• Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.

• Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.<