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Group Leader, Supplier Quality Management

Group Leader, Supplier Quality Management

CatalentKansas City, MO, US
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Group Leader, Supplier Quality Management

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply 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 in Kansas City, MO is hiring a Group Leader, Supplier Quality Management. This role will support the state of regulatory compliance at the Kansas City site through leadership of the Supplier Quality Management program.

This is a full-time, salary, onsite position. This is a 1st shift position. (Monday-Friday 7am-3 : 30pm)

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

  • Aide in the creation of the annual audit schedule and perform supplier assessments in timely fashion.
  • Review completed questionnaires and perform supplier risk assessments to determine frequency of reassessment.
  • Evaluate new supplier requests and maintain the approval supplier list to ensure supplier information is up-to-date and accurate.
  • Identify the need for site level supplier quality agreements, track and initiate their renewal.
  • Approval of purchase specifications.
  • Communicate with Catalent Global Supplier team and suppliers to schedule and perform on-site audits to evaluate the facility, procedures, processes and quality systems.
  • Formal write-up of audit report, assessment of supplier's systems.

The Candidate

  • Requires a Bachelor's degree in a related field with 3+ years of supplier quality experience under GMP regulatory requirements or related quality assurance experience.
  • Requires to be trained on all related GMP SOPs and abide by the rules and regulations associated with the maintenance of these documents.
  • GMP regulatory knowledge based in US, European, and other countries a plus.
  • 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.
  • Required leadership skills include excellent interpersonal and communication skills with all levels of stakeholders, the strong ability to lead, mentor, train, motivate, direct and empower a team, influence and lead change, contribute strategic, analytical insight for problem solving and partner with cross functional teams to identify gaps, develop and implementation of continuous improvement ideas.
  • Physical Requirements : Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds and occasional requirement to work in cold environment to fill orders (walk-in refrigerator / freezer).
  • Why you should join Catalent :

  • Defined career path and annual performance review and feedback process.
  • Diverse, inclusive culture.
  • Positive working environment focusing on continually improving processes to remain innovative.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • 152 hours of PTO + 8 paid holidays.
  • Several Employee Resource Groups focusing on D&I.
  • Dynamic, fast-paced work environment.
  • Community engagement and green initiatives.
  • Generous 401K match.
  • Medical, dental and vision benefits effective day one of employment.
  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!
  • WellHub- program to promote overall physical wellness.
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
  • 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.

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    Supplier Quality Leader • Kansas City, MO, US

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