Senior Manager, Quality Operations

Senior Manager, Quality 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.

The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Senior Manager – Quality Operations who coordinates and manages GMP regulated activities from early-stage development through commercial product.  This individual is responsible for oversight of operations and release of product.

This is a full time, salaried role, Monday – Friday – days. 8:00AM – 5:00PM

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

• Manages all QA Operations activities related to the oversight of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Deviations
• Manages all QA Operations activities related to the oversight, review, and approval of Materials Management and Supply Chain activities
• Manages the Environmental Monitoring Program and the associated budget and invoices, including Controlled Environments and Clean Utilities
• Review, assessment, and implementation of Change Controls
• Performs disposition activities for products and materials
• Provides support during compliance inspections conducted by external and internal sources (i.e. health authorities, clients, self-inspections)
• Teams with cross-functional operations personnel to critically evaluate and continuously improve manufacturing control systems
• Develops and maintains Training Plans for QA Operations
• Monitors team productivity, identifies issues and root causes, and develops any resolution or mitigation plans
• Performs ongoing performance reviews and development of staff
• Assists with talent recruitment and new hire onboarding and training
• Communicate with clients and support client needs
• Author and review Quality Technical Agreements with clients and suppliers
• All other duties as assigned

The Candidate

• Bachelor’s degree in a scientific discipline is required, preferably in physical Science or Chemistry;
• Minimum of twelve (12) years of progressive experience in a GMP environment required;
• Minimum of eight (8) years of Quality Assurance experience in support of GMP production required;
• Prior supervisory experience required;
• Management of all QA Operations Associates and QA Environmental Monitoring Specialists;
• Working knowledge of GMPs and their application to pharmaceutical manufacturing required;
• Knowledge of FDA guidance documents is required;
• Previous exposure to investigations and product complaints required;
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
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