Manager, Quality Assurance

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

About 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.

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.

Benefits

• 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.

Schedule

Monday - Friday, Days

Location

Kansas City, MO (100% Onsite)