Supplier Quality Assurance Senior Specialist

Supplier Quality Assurance Senior Specialist

Position Summary

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 Supplier Quality Assurance Senior Specialist. The Supplier Quality Assurance Senior Specialist will assure compliance to national and international standards by managing or completing tasks that support the Global Comparator and Depot Supplier Quality Management and Clinical Packaging Network site Supplier Programs. They will support and participate or lead in the maintenance of the audit schedule and approved supplier list.

This is a full-time, on-site salary position. This position can be located at our Kansas City, Philadelphia or San Diego sites.

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

• Manage the approved supplier list for Global Supplier Quality and network supplier programs
• Independently plan, conduct, review and report site and questionnaire audits including third-party and outsourced audits for new and existing domestic and international suppliers in line with Network procedures
• Ensure supplier records are initiated and maintained for all supplier approval documentation including audits, assessments, and quality agreements
• Complete Supplier Quality Agreements, Supplier Audits, (questionnaire and site), Risk Assessments, Risk Control Plans, License Review, Change Controls, Actions and Follow-up’s
• Evaluate and perform impact assessments and execute action plans for supplier change notifications (i.e. facility change, supplier change controls)
• Monitor/support supplier license renewal for applicable services
• Liaise with suppliers to ensure compliance to regulatory changes or updates (globally)
• All other duties as assigned

The Candidate:

• A High School Diploma or General Education Diploma with at least six years of experience in Quality or Pharmaceutical is required; A Bachelor’s Degree in a Scientific or Engineering discipline with at least three years of experience in pharmaceutical quality OR High School Diploma or General Education Diploma with at least five years experience in Quality auditing is required
• Prior Supplier Auditing experience and experience in writing supplier audit reports, certified auditor or lead auditor credentials are preferred
• Experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution preferred
• Prior experience in JDE and Trackwise systems preferred
• Demonstrate project management skills with an ability to prioritize, plan, evaluate & execute deliverables for established tactical goals
• Position is site based and candidate must be able to commute to one of the Clinical packaging sites at Catalent located in the US region (San Diego, PHL or KCM)
• Ability to travel both domestic and abroad to Catalent sites or Catalent supplier locations as required ~25% travel
• Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above