Catalent Pharma Solutions
Pharmaceutical
Director,Quality
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“Director, Quality at Catalent Pharma Solutions. Skills: Quality Assurance, Regulatory Compliance, Leadership, cGMP. Create and implement Business Unit quality strategy. Create and implement global quality policies”
Industry & Context.
internal investigations; Error Reduction
100% on-site
What They're Looking For.
Must Have
BS Degree (or regional equivalent) in a Science, Engineering or Pharmaceutical discipline required, 10+ years of experience working in a chemical, pharmaceutical, food or relevant industry, 5+ years experience in QA/RA areas with progressive responsibilities, Experience in managing people, providing leadership, and implementing developmental plans for personnel, Direct experience and working knowledge of Validation principles, Working knowledge of US and International cGMP regulations, experience working directly with the local and international regulatory agencies, demonstrable record of implementing and maintaining quality systems, laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics
Nice to Have
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
What You'll Do.
Create and implement Business Unit quality strategy
Create and implement global quality policies
Harmonize BU quality processes
Create and sustain a site culture
Lead site Quality Objectives development
Lead site Quality Plans development
Lead Quality Management Reviews
Oversee site Quality Assurance functions
Oversee regulatory compliance functions
Oversee Performance Management Program actions
Provide professional development counseling
Provide informal performance appraisals
Provide formal performance appraisals
Oversee talent development
Oversee success planning
Investigate cGMP issues
Investigate customer complaints
Review GMP documentation
Approve GMP documentation
Ensure cGMP compliance
Ensure clarity of documentation
Integrate processes with other sites
Harmonize procedures with other sites
Coordinate customer audits
Coordinate regulatory audits
Submit Catalent responses
How You'll Work.
Team & Collaboration
Working with the BU VP Quality; Working with the other CSS Quality Directors; Working with the General Manager; Working with product team
Communication Scope
providing feedback
Process & Methodology
laying out a strategic plan, overseeing the tactical implementation
Full Job Description
**Director, Quality** **Position Summary:** * 100% on-site Catalent’s Kansas City facility is home to our Clinical Delivery Services and Biologics Analytical Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. 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. **The Role:** * 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. * Site Leadership: As a member of the Site Leadership Team working with the General Manager to create and sustain a site culture of Safety, Quality Performance, Operational Excellence, Continuous Improvement, Error Reduction, Regulatory Compliance, and sound fiscal responsibility. Lead the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc. * Department Leadership: Overall responsibility for the site Quality Assurance and regulatory compliance functions. Oversee and execute all Performance Management Program (PMP) actions for the site Quality Assurance department. This includes professional development counseling, informal and formal performance appraisals and feedback, and talent development/success planning. * Responsible for internal investigations on cGMP issues, trends and customer complaints. * Review and approve GMP docu
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