Associate Director Quality Assurance

Associate Director, Quality Assurance

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.

This is a full-time salaried position, onsite out of Philadelphia, PA. The Associate Director, Quality Assurance is responsible for providing leadership and support within Catalent's Philadelphia site. The Associate Director, QA is accountable for the group providing Quality Assurance support to clinical & commercial manufacturing operations within the facility. This includes but is not limited to shop floor quality, batch record review, deviation management, customer interface, improving activities related to process and support to business demands. The Associate Director, Quality Assurance is responsible for directing the QA teams for the manufacturing floor / area, batch record review / release activities, commercial customer support. The position will have 4 to 5 direct reports and a total of 30 to 40 indirect reports. Will work directly with QA managers / supervisors and operations to improve processes and procedures. Responsible for ensuring the site is following cGMP guidelines, adherence to Catalent Corporate Quality Policies and applicable Catalent Clinical Supply Services quality standards across the area of focus. Position requires partnership with other functional areas (e.g. Product Development, Project Management, Operations, Customer Service, Packaging etc.) to ensure continued compliance for the area / site. Will provide directional support and as required, hands-on, leadership to drive actions and enhancements to the QMS. Will be a key decision maker and point of escalation for operations, customer and internal concerns / issues.

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

• Quality liaison for clients and internal customers; is expected to become the owner or escalation point for client requests / issues
• Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus
• Participate in Regulatory Inspections and Customer Audits, etc
• Participate in site and customer meetings / communications and be directly involved in critical projects / issues
• Establishes goals and monitors performance through monthly, quarterly, and annual summaries and metrics
• Present summary data to site management on a regularly scheduled basis
• Provide QA Technical recommendations based on trend analysis to eliminate future problems
• Participates in project meetings to provide input with respect to compliance to cGMP requirements
• Other duties as assigned

The Candidate

Why You Should Join Catalent :

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma, and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.