Director, Quality

Catalent • Kansas City, MO

5d • Onsite

About The Position

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.

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.

Nice To Haves

• 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.

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: Senior