Hiring: Director, Quality Company: Catalent Location: Kansas City, MO Job Posted Time: 2026-09-03 11:32:21 Employment Type: On-site Target Skills & Keywords : CSS, Quality Assurance, Regulatory Compliance About the job Experience: •25 years of experience providing analytical services for stand-alone and integrated biologics projects. •10+ years of experience working in a chemical, pharmaceutical, food or relevant industry with 5+ years experience in QA/RA areas with progressive responsibilities. •Over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Required Skills: •Catalent Pharma Solutions is hiring a Director of Quality in our Clinical and Specialty Services division who will have a focus on Global Leadership, Site Leadership, Department Leadership and Personal Leadership. This is a Senior Quality Assurance leadership role in a fast-paced, customer-focused organization. •Global Leadership: Working with the BU VP Quality and the other CSS Quality Directors to create and implement Business Unit quality strategy, global quality policies, BU quality process harmonization, etc. •Lead and oversee internal investigations on cGMP issues, trends and customer complaints. •Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity. •Lead and oversee process integration and procedural harmonization with other CSS sites. •Accountable for customer and Regulatory Audits, including coordination and submission of Catalent responses. •10+ years of experience working in a chemical, pharmaceutical, food or relevant industry with 5+ years experience in QA/RA areas with progressive responsibilities. Qualifications: •BS Degree (or regional equivalent) in a Science, Engineering or Pharmaceutical discipline required. Compensation: •Generous 401K match and Paid Time Off accrual Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!