Manager, Quality Assurance

Manager, Quality Assurance

Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

We have an opportunity for a Manager, Quality Assurance to join our team. In this role, you will lead continuous quality improvement efforts at the site. You will supervise quality assurance associates, ensuring daily activities run smoothly and issues are resolved promptly. This position involves reviewing and approving critical quality documentation and supporting compliance with Good Manufacturing Practices. You will play a key role in maintaining high standards and fostering a culture of quality.

Shift: Monday- Friday, Days Location: Kansas City, MO 100% Onsite

The Role

• Supervise quality assurance associates, providing direction for daily activities and resolving issues with internal and external clients.
• Prepare and deliver performance reviews for assigned associates in both oral and written form.
• Review and release batch documentation.
• Review and approve quality events such as deviations, investigations, document control, and change control.
• Review and approve validation documents, including Installation Qualification, Operational Qualification, and Performance Qualification.
• Review construction and facilities maintenance activities and plans for quality assurance compliance.
• Author or revise quality assurance procedures and forms.
• Identify deviations or investigations during manufacturing or packaging processes and provide direction on appropriate actions.
• Lead or assist in Good Manufacturing Practice training, including mentoring and developing direct reports.
• Perform packaging audits.
• Meet deadlines according to agreed timeframes and communicate adjustments as needed.
• Other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor's degree in a scientific discipline with 5+ years of Quality Assurance experience in a Good Manufacturing Practice environment.
• Lift up to 30 pounds.
• 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.

Preferred Skills & Background

LEAN, Six Sigma, or American Society for Quality certification preferred.

Why You Should Join Catalent

• Defined career path with annual performance reviews and feedback process.
• Diverse and inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

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.