What are the responsibilities and job description for the Manager, Commercial Quality Assurance position at catalent?
Manager, Commercial Quality Assurance
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.
Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
The Manager, Commercial Quality Assurance will provide quality oversight and a consistent quality approach for the Commercial Manufacturing, Packaging and Quality Control testing teams. The Manager, Commercial Quality Assurance requires the ability to lead and develop Quality Assurance professionals in daily activities, supporting the review and release of commercial drug products manufactured and packaged internally for the site.
Regular working hours: Monday - Friday; 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch.
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
Supervise Quality Assurance team; oversee allocation of workload
Acquire product-quality knowledge and act as the quality expert for the product-quality history throughout the product life cycle
Lead in the development of a climate of quality and safety within the teams by identifying and monitoring quality and safety standards, ensuring adherence to all regulatory guidelines, cGMP guidelines, and Environmental Health and Safety regulations as required by the job function, and reviewing validation protocols and completed documents, including process qualification protocols for validations of commercial processes.
Review and approve Change Control documentation, Deviation and Laboratory Investigations and Issue Reviews and CAPA.
Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition
Review and update Standard Operating Procedures (SOPs) for GMP compliance
Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility
Perform other duties as assigned.
The Candidate
Master’s degree with at least 9 years of professional experience in the pharmaceutical industry and at least 4 years in a QA role (or)
Bachelor’s degree with at least 10 years of professional experience in the pharmaceutical industry and at least 5 years in a QA role (or)
Associate degree with at least 11 years of professional experience in the pharmaceutical industry and at least 6 years in a QA role required.
At least 3 years of prior supervisory experience required; management experience preferred.
Position requires the capacity to handle and manipulate objects using hands and arms.
Some exposure to hazardous chemicals and other active chemical ingredients.
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
Medical, dental, and vision insurance.
401(k) retirement savings plan with company match.
Fast-paced, dynamic environment.
152 hours of PTO 8 paid holidays.
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. 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.
