Senior Director, Quality

Senior Director, 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.

• 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 requirements 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.

• Bachelor’s or Master’s Degree in science, pharmacy or related discipline is required.
• Extensive experience (10+ yrs) in biologics is a requirement.
• Experience with drug substance manufacturing is required. Experience with drug product manufacturing is preferred.
• Demonstrated business acumen and ability to manage through difficult discussions with clients.
• Demonstrated experience of successfully leading Quality organizations, preferable in a matrix‑style organization.
• Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.
• Proven experience in driving substantial improvements of quality performance across a broad range of initiatives including development and recruitment of talent, process improvements, elimination of exceptions/SOP standardization.
• Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.
• 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.

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic, fast‑paced work environment
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment

Catalent is an Equal Opportunity Employer, including disability and veterans.