Position Summary:

Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Manager, Quality Management Systems for the Quality Assurance department. This person will manage a compliance and regulatory team responsible for Compliance and Training activities at the site, which includes overseeing the internal/external audit programs as well as the Training Department at the Somerset site. The Senior Manager, Quality Management Systems must possess expert knowledge of cGMPs, compliance, and a good understanding of the Quality Management Systems. This person must be flexible, have well-developed organizational skills, and have the ability to interact with all levels of management.

This is a full-time position: Monday – Friday, 8:00AM – 5:00PM

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 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.

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

• Lead audits of Catalent Somerset site to ensure compliance with foreign and FDA cGMPs, Corporate, and Pharmaceutical Development standard operating procedures and policies

• Implement process improvement initiatives related to the audit programs and training to ensure that the organization's requirements are met compliantly and in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit

• Monitor and oversee the Supplier Audit program, trends, findings, and related Trackwise Records/CAPAs, and oversee the management of Quality Assurance Agreements and Site Licenses

• Ensure that written responses are provided and appropriately address the observations for customer audits, internal audits, corporate audits, and regulatory inspections

• Provide audit findings, quality metrics, and tracker information to Senior Management as required

• Approve department procedures and assist in the development of new procedures and/or revisions of existing procedures as required

• Maintain responsibility for interpretation and implementation of cGMP’s and other FDA regulations and pronouncements

• Provide staff members with leadership, guidance, mentoring, coaching, and feedback against performance and development objectives

• Assign project assignments to staff members with appropriate due dates for project completion, and ensure that departmental goals and project timelines are being met by the team

• All other duties as assigned;

The Candidate

• Bachelors of Science in Chemistry, Microbiology, Pharmacy, or related is required; Masters degree is preferred

• Ten or more years of experience working in quality assurance or quality control in the pharmaceutical industry is required

• Must have experience in a management or leadership role

• Prior experience with regulatory and compliance audits is required

• Working knowledge of the regulatory process is required

• One or more years of experience in compliance, auditing, and data review strongly preferred

• Understanding of FDA and EU CGMPs and DEA regulations pertaining to clinical trial and commercial activities is strong preferred

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

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 + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401K match

• Company match on donations to organizations

• 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.

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) .