Manager, Commercial Quality Assurance

Full-time - Manager

Greenville, NC

Chemical Manufacturing

About the position

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.

Responsibilities

• 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.

Requirements

• Master's degree with at least 9 years of professional experience in the pharmaceutical industry and at least 4 years in a QA role
• Bachelor's degree with at least 10 years of professional experience in the pharmaceutical industry and at least 5 years in a QA role
• 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 may be considered in place of external experience.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement savings plan with company match.
• Fast-paced, dynamic environment.
• 152 hours of PTO + 8 paid holidays.