Director, QA Clinical Operations

Director, Quality Assurance Clinical Operations

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. 

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

The Director, Quality Assurance Clinical Operations is responsible for leading and managing quality assurance functions supporting clinical operational activities, ensuring timely and compliant delivery of products while maintaining high-quality standards. The incumbent will oversee real-time batch record review, QA-OTF support, client-facing QA activities, and deviations management. The Director works closely with senior management to meet operational and quality goals and will also be instrumental in ensuring the execution of key deliverables and maintaining the "Patient First" culture.

This is a full-time on-site position.

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 

• Responsible for staffing and overseeing training, effective execution of responsibilities, professional development of employees and conducting performance reviews.

• Outlines and executes department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success.

• Directs the real-time batch record review activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelines.

• Provides investigation direction, support, and department approvals.

• Ensures investigation CAPA actions are clearly defined, effective in resolving the root causes and are implemented timely.

• Oversees Client facing personal supporting clinical operations in the roles of Client QA.

• Directs QA-OTF activities supporting clinical activities including central services and manufacturing operations.

• Facilitates QA support and works closely with other Catalent functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured.

• Other duties as assigned. 

The Candidate 

• Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology preferred).

• 10+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role.

• 8+ years of leadership experience including performance management.

• Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.

• Exposure to contract manufacturing a plus. Ability to quickly learn new and novel manufacturing processes supporting new clients.

• Ability to sel