Manager, Quality Assurance

Manager Quality Assurance

About Site

Catalents 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 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

• Bachelors 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 Catalentsponsored 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 7000 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.

Visit Catalent Careers to explore career opportunities.

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 . 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

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California Job Seekers can find our California Job Applicant Notice HERE.