Director, Quality

Regulatory Jobs; Kansas City (MO); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Generous 401K match

Paid Time Off accrual

Medical/dental/vision benefits

Job summary

Catalent’s Kansas City facility is a Center-of-Excellence for Biologics Analytical Services, and the Director of Quality leads the CSS organization with a strong focus on global quality strategy, regulatory compliance and site performance. This senior role requires extensive QA/RA experience, cross-functional leadership, and a proven history of improving GMP systems.

Responsibilities include policy development, audit readiness, investigations, and ensuring robust validation and documentation

Qualifications

• BS Degree (or regional equivalent) in a Science, Engineering or Pharmaceutical discipline required.
• 10+ years of experience in a chemical, pharmaceutical, food or relevant industry with 5+ years in QA/RA.
• Experience in managing people and developing personnel.
• Direct experience with Validation principles (process, equipment, systems, analytical methods, cleaning, transportation).
• Working knowledge of US and international cGMP regulations and regulatory agencies.
• Proven record of implementing and maintaining quality systems and driving improvements.
• Leadership experience at Catalent (programs such as NGGL, GOLD, LEAD Now, GM Excellence, GROW) may be considered in place of external experience.

Responsibilities

• Global Leadership: develop and implement quality strategy, policies and harmonization across business units.
• Site Leadership: lead site Quality Objectives, Plans and management reviews with the Site Leadership Team.
• Department Leadership: oversee QA/RA functions and performance management actions.
• Lead internal investigations on cGMP issues, trends and customer complaints.
• Review and approve GMP documentation and validation reports for cGMP compliance.
• Drive process integration and procedural harmonization across CSS sites.
• Coordinate customer and regulatory audits and Catalent responses.
• Perform other duties as assigned.

Skills

Leadership

People management

Regulatory knowledge

Quality mindset

Problem solving

Education

BS Degree in Science/Engineering/Pharma

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 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.

The Candidate:

• 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.

Why You Should Join Catalent:

• 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

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

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