Senior Manager, CAPA

Senior Manager, CAPA

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.

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.  Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The primary responsibilities of the Senior Manager, CAPA include managing the Corrective and Preventive Action (CAPA) system, tracking, trending, and ensuring timely closure of CAPA investigations and follow-ups. This position will also involve the preparation of actions, facilitation of CAPA meetings, and communication of CAPA-related metrics to key stakeholders. The CAPA Manager will collaborate with cross-functional teams to ensure quality issues are addressed effectively and continuously improved.

This is a full-time on-site position, M-F 8am-5pm

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:

• Oversee and manage the CAPA system, ensuring proper documentation, timely initiation, tracking, trending, and closure of CAPA investigations.
• Prepare and present CAPA-related metrics and summary reports on a monthly, quarterly, and annual basis.
• Lead and facilitate CAPA Review Board meetings, ensuring follow-up on actions and ensuring CAPA closure within agreed timelines.
• Collaborate with the MTO team to support investigations into product and process deviations, ensuring appropriate corrective and preventive actions are taken.
• Coordinate with various departments (e.g., Manufacturing, Quality Control, Regulatory) to implement CAPA actions and evaluate their effectiveness.
• Conduct training for internal stakeholders on CAPA procedures, root cause analysis, and process improvement.
• Assist in the preparation and review of annual product quality reviews and regulatory compliance reports.
• Monitor and ensure compliance with all relevant quality standards, regulations, and guidelines (e.g., cGMP, FDA, ISO).
• Support internal audits, supplier audits, and customer audits with CAPA-related data and reports as required.
• Ensure continuous improvement within the CAPA process by reviewing trends and identifying opportunities to improve efficiency and effectiveness.
• Other duties as assigned

The Candidate:

• Bachelor’s Degree in Life Sciences, Chemistry, Microbiology, or a related field, or a combination of education and relevant experience in the pharmaceutical or biotechnology industry.
• A minimum of 3-5 years of ex