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. Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent’s cell therapy network including our European Center of Excellence for cell therapy. In support of Manufacturing schedule, the Manager, Quality Assurance Compliance provides Quality Assurance guidance and oversight on Quality Management Systems (QMS). This includes supporting Electronic Document Management System (EDMS) and reviewing executed GMP documentation. Position is 100% on site at our Princeton, NJ facility and will be on 1st Shift Monday-Friday 8AM-5PM. Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. The Role: • Lead team supporting Quality Management Systems (QMS) with QA review and decisions on; CAPAs, Change Controls, Customer Complaints, operational deviations, and Self-Inspection as needed. • Manage facility’s Document Archive. • Manage Quality Assurance portion of training documentation. • Lead and support site initiatives for Inspection Readiness, Quality Council and KPIs • Lead the oversight to ensure alignment with Catalent policies & standards. • Head administration role for Electronic Document Management System (EDMS) at Princeton facility as needed. • Other duties as assigned The Candidate: • Bachelor’s Degree required with a minimum of 7 years of relevant industry experience in a GMP regulated environment. • 5 - 7 years of experience in a Quality Assurance role within a Manufacturing setting, experience in a GMP Manufacturing setting required, clinical experience preferred. • 2 - 4 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict. • Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. • Experience in supporting or leading quality management review; Prior experience in managing KPIs preferred; Prior experience in audit management preferred. • Ability to work under tight and emerging deadlines; Fluent in speaking and writing English. • Highly organized with attention to detail and possess strong written and verbal communication. Ability to work on cross functional teams. Ability to lead team discussions and facilitate meetings. • Potential for 5% travel to other sites annually While performing the duties of this job, the employee is frequently required to stand; sit and talk or hear. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. Why you should join Catalent: • Defined career path and annual performance review and feedback process • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives • Dynamic, fast-paced work environment • Generous 401K match and Paid Time Off accrual • Medical, dental and vision benefits effective day one of employment • 19 days of PTO 8 paid holidays • Tuition Reimbursement • GymPass 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. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. 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. 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. Catalent = Catalyst Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if… You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT). You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world! You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people. You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first. You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU! See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.