Senior Director, Site Head of Quality

• ◆100% onsite

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 Senior Director of Quality is a member of the site leadership team and is expected to lead in a manner that promotes and drives a Patient First culture throughout the organization. The Senior Director of Quality is directly responsible for the Site Quality Directors/managers under their responsibility and drives "One Catalent" quality standards across the organization, ensuring that the systems necessary to produce products in conformance with good manufacturing practices and standards are implemented and followed. The Senior Director of Quality is also responsible for establishing and maintaining positive customer relationships and providing direction to the customer and organization to address critical performance issues.

• ◆Partner effectively with other functional leaders (Process Development, Operations, Program Management etc.) and Site General Manager to develop and maintain a meaningful and robust Patient First and Quality culture across all aspects of the business.
• ◆Champion, through clear and visible advocacy, Catalent's Quality Management System (QMS), and ensure strong technical and leadership capability at all levels of the Quality organization.
• ◆Responsibility for ensuring the site Quality teams (100-200 HC) is staffed with high caliber Quality leaders and professionals, driving strong and effective performance culture at all levels across the sites, and creating a strong succession pipeline for key leadership roles.
• ◆Define activity-based cost models and establish and execute a budget that is in-line with the

of the business to deliver on the testing, release, and QMS commensurate with the needs of the business to operate effectively and efficiently.

• ✓Ensure appropriate metrics and reporting/escalation processes are in place and being utilized to drive and improve operational execution and drive appropriate corrective actions.
• ✓Drive actions and remediation as required to meet the quality performance and standards sets for the site.
• ✓Drive execution and outcomes on critical deviations providing clear direction and oversight including the review and approval of critical deviations as well as effective CAPA plans.
• ✓Other duties as assigned.