Associate Director, Quality

Associate Director, Quality

Job 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.

Our Manassas, Virginia site is a part of the Consumer Health division and provides expanded capabilities in soft chews and lozenges. With extensive development and manufacturing expertise and a wide range of flavors, ingredients, and colors available, we can work with complex formulations to help create engaging new products consumers will love.

Reporting to the Vice President Quality, Consumer Health and as a member of the Site Leadership Team the Associate Director, Quality is accountable for the direct management and guidance in the Quality and cGMP aspects of the organization. The individual will act as the Leader of Food Safety, Quality and Regulatory activities in the manufacturing site and will be accountable for maintaining the highest standard of Dietary Supplement Manufacturing, Food Safety, Food Quality and Food Security. The Associate Director, Quality will ensure regulatory compliance with all applicable Federal, State, and Local regulations and compliance to customer and internal product specifications.

The Job

• Responsible for ensuring that the necessary systems are in place to support compliance with Dietary Supplement cGMP requirements for the Catalent Wellness facility, processes and people for the markets in which its products are sold.

• Food Safety and Quality Team responsibility: developing, validating, verifying and maintaining Food Safety Plans and Pre-requisite programs.

• Direct all functional and operational aspects of the Quality Assurance program to ensure compliance with all appropriate regulations and standards.

• Supervise, provide guidance and leadership to plant Quality organization and development of the same.

• Lead client, third-party, and FDA quality assurance audits along with senior management.

• Develop and refine plant measurement techniques, control plan and corrective action activities. Liaise with various departments to modify standard operating procedures, and create new ones as needed.

• Review and ensure compliance with plant GMP’s, HACCP, sanitation and pest control procedures and standards.

• Ensure internal compliance assessments of the site are appropriately managed and that responses to resolve deficiencies are provided and communicated in a timely manner.

• Execute against company established Key Performance Indicators for Quality in collaboration with Operations.

• Other duties assigned.

The Candidate

• Bachelor’s degree in Food Safety, Microbiology, Chemistry, Food Science, Engineering, or other science related field required.

• Knowledge of the industry's regulatory environment, specifically with 21 CFR 111 and 117 required.

• 5+ years of progressive Quality experience with