Associate Director, Commercial Quality Assurance

Associate Director, 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 Associate Director, Commercial Quality Assurance provides leadership and support in delivering technical excellence in compliance with cGMP, continuous improvement as well as meets internal business targets while exceeding client expectations. The Associate Director, Commercial Quality Assurance provides quality assurance leadership and oversight for all commercial manufacturing and laboratory operations onsite and at contract organizations (CMOs and CPOs).

The Role

• Act as Commercial QA SME during FDA, non-domestic and client audits and lead preparation of responses to all audit observations, particularly those related to Commercial Quality Assurance findings.

• Lead site cross-functional team effort to drive all commercial CAPA commitments for audit responses and eQMS events to timely completion and effectiveness evaluation.

• Lead the team-based approach for review and verification of drug product quality in manufacturing, packaging and testing records to ensure that only compliant product is released and non-conforming materials are investigated and dispositioned appropriately.

• Lead in the development of a culture, and supporting systems, to drive open communication, participation and intra/inter-departmental idea-sharing to build an engaged team; advance and model company values and leadership commitments; ensure the highest levels of quality, compliance and integrity are adhered to in all interactions.

• Direct operations within Commercial Quality Assurance while maintaining a continuous improvement philosophy focused on improved compliance, right-first-time and process efficiency while creating an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the commercial organization.

• Establish and maintain active KPIs for the functional measures within Commercial Quality Assurance including periodic reporting for the KPIs; monitor and trend key Quality data for internal and external commercial supplies in support of the S&OP scorecard program.

• Oversee development and performance management of direct reports including identifying learning and cross training opportunities as well as providing coaching and mentoring, goal setting, performance evaluations and feedback.

• All other duties as assigned.

The Candidate

• PhD with at least 7 years of professional experience in QA/QC pharmaceutical manufacturing or;

• Master’s degree with at least 9 years of professional experience in QA/QC pharmaceutical manufacturing or;

• Bachelor’s degree with 10 years of professional experience in QA/QC pharmaceutical manufacturing.

• At least 4 years of leadership/management experience required with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results to achieve corporate, site and departmental objectives.

• Extensive technical skills in solid dose manufacturing and/or packaging; experience in contract manufacturing preferred.

• Experience leading audit preparations, electronic quality management systems such as deviation management, analytical investigations (OOS), CAPA and change control