Senior Director, Quality
On-site · Kansas City, Missouri, United States
Job Summary
Senior Director, Quality at Catalent Kansas City leads the Quality unit for the Kansas City site (Pharma/Consumer Health and KC campus) ensuring compliance with regulatory requirements, developing and maintaining the Quality Management System, and driving CI and Patient First culture. Responsibilities include setting strategy and vision for Quality Operations, aligning with General Managers, managing audits and regulatory interactions (FDA/EU and others), approving materials and specifications, overseeing document control and annual product reviews, and leading a large multi-site team (50+ employees) to meet quality metrics and on-time delivery. Requires a BS in Science; MS preferred, 10+ years in pharma/medical device quality with Biologics/sterile product experience, strong risk management, leadership experience, and knowledge of cGMP/ICH and regulatory guidelines.
Required Qualifications
- Bachelor of Science required; MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology
- Experience leading Quality Operations at a manufacturing site operation for 5+ years (e.g. Quality Operations, QC Operations, Manufacturing)
- 10+ years’ experience in pharmaceutical or medical device industry with increasing levels of responsibility and leadership in quality assurance, compliance and quality control
- Experience with Biologics / sterile drug product manufacturing is strongly preferred
- Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments
- Demonstrable leadership experience at Catalent or equivalent with leadership programs considered
- Strong understanding of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory across manufacturing disciplines
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