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Director, Quality Assurance Operations - Madison Wisconsin
Company: Disability Solutions
Location: Madison, Wisconsin
Posted On: 04/04/2025
Director, Quality Assurance Operations 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 Assurance Operations has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.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 - - Manages QA resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.
- Manages the oversight, review and approval of deviations and investigations pertaining to CGMP production and testing.
- Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.
- Understands the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
- Supports the establishment, preparation, and communication of site quality metrics. Identifies and works with function areas as appropriate to facilitate improvements.
- Establishes functional and overall training expectations for Quality Assurance personnel engaged in the review and disposition of GMP products.
- Supports the preparation of Product Quality Reviews; tracks and trends the performance of validated programs in support of continuous process verification.
- Other duties as assigned. -The Candidate -
- Doctorate Degree in STEM discipline with minimum of 8 years related experience OR; Master's Degree in STEM discipline with minimum of 12 years related experience OR; Bachelor's Degree in STEM discipline with minimum of 15 years related experience,
- Minimum 6 years of leadership experience.
- Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
- Take responsibility for direct reports' performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly.
- Excellent written and verbal communication skills with internal and external customers.
- Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
- Functions as a strong Quality liaison to other functional department, providing meaningful quality support and ensuring productive cross-functional communication.
- 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 -
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