Catalent
Supplier Quality Regional Lead
Catalent, Trenton, New Jersey, United States,
Supplier Quality Regional Lead
Position Summary:
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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.
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.
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
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 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.
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.
#J-18808-Ljbffr
Position Summary:
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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.
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.
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
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 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.
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.
#J-18808-Ljbffr