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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 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

The anticipated salary range for this position in Maryland is $ 112,950 - $153,092 plus bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.”

Why You Should Join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 152 hours of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• 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

• Community engagement and green initiatives

• Generous 401K match

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• 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.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .