Director, Quality

Catalent Pharma Solutions • Kansas City, MO

3d • Onsite

About The Position

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 documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity. Responsible for process integration and procedural harmonization with other CSS sites. Accountable for customer and Regulatory Audits, including coordination and submission of Catalent responses. Other duties as assigned.

Requirements

• 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 with 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, including validation of processes, equipment, systems, analytical methods, cleaning and transportation.
• Working knowledge of US and International cGMP regulations and experience working directly with the local and international regulatory agencies.
• Must have a demonstrable record of implementing and maintaining quality systems, laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics.
• 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.

Responsibilities

• 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.
• 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.
• 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 documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity.
• Responsible for process integration and procedural harmonization with other CSS sites.
• Accountable for customer and Regulatory Audits, including coordination and submission of Catalent responses.
• Other duties as assigned.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director