Supplier Quality Regional Lead

Supplier Quality Regional Lead

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.

This is a full-time salaried position: Monday – Friday, 1st shift.

Catalent in Somerset, NJ is home to oral solid dose manufacturing operations as part of the Oral and Specialty Delivery (OSD) business unit. On site we have our state-of-the-art laboratory, clinical, and commercial manufacturing plant for oral dose forms in addition to being the Catalent Center of Excellence for handling Highly Potent Active Pharmaceutical Ingredients.

As an integral member of the Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading the Supplier auditors performing Supplier Audits regionally and in accordance with their assigned schedule in support of supplier integrity and oversight.

The Supplier Quality Regional Lead will oversee management of the regional Supplier Auditor Team and appraisal processes including routine Goal and Objective discussions and developmental plans in place for individuals.

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:

• Oversight and leadership for the regional Supplier Auditor Team performing audits, generation of audit reports and management of supplier CAPA (Corrective and Preventative Action) to ensure required actions are completed within the required timeframe

• Support to Supplier Quality site teams on routine queries and guidance

• Manage Supplier notification mailbox to ensure active management and delegation within the supplier team and associated Quality Compliance Assessments are delegated appropriately

• Ensure the regional team performing the audits assigned develop a planned audit schedule to maximise audits conducted during one trip i.e. grouped audits based on location 

• Development of metrics to provide visibility of audits due, planned audit dates, Audits complete, Audit reports process timelines and overdue audits

• Development for collation and communication of common finding categories to allow identification of risk areas across Supplier base

• Proactive planning to ensure maintenance of audits assigned to the Supplier auditor team, to mitigate overdues

• Collaborate, align, and foster cross-functional business relationships within Global functional groups such as Procurement, Sites and Supply Chain to ensure any risks are identified, mitigated, and communicated

• 40% travel expectations annually (domestic & international)

• Other duties as assigned

The Candidate:

• Bachelor’s Degree, required; Certified auditor or lead auditor credentials, preferred

• Five years+ auditing experience and supervisory experience, required

• Experience working in an auditing role within the Pharmaceutical/Medical Device industry

• Knowledge and understanding of the following principles and guidelines: EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices

• Working knowledge of industry related guidelines such as ICH Q7, GHTF, and IPEC

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

• Demonstrable leadership experience at Catalent (including but no