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 
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness 
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.