Quality Assurance Manager

Quality Systems Manager

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.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging.  Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.  Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Systems Manager.  The Quality Systems Manager must be flexible and have well-developed organizational skills and the ability to interact with all levels of management. The Manager must be an initiative-taker, results oriented individual with ability to articulate, receive, disseminate, and analyze data. They are responsible for the management of the Quality Systems Management department. The Manager is responsible for the development, implementation and maintenance of quality assurance standards and procedures as well as quality systems.

This is a full-time, salary role.   This is onsite.  This position is a 1st Shift role.

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:

• Provide timely and accurate reports and assessments of problems or potential problems to the Associate Director, QMS
• Lead the implementation of new Quality /Compliance programs/systems for the site
• Assign project deliverables to Team members with appropriate due dates for project completion
• Provide direction to the Training Administrator on training objectives and projects
• Oversee the Compliance Wire administration for procedural based training, and other training needed for performing tasks
• Oversee department management of documentation, logbooks, records archiving, training record files/folders, etc
• Review Quality System documents and ensure compliance with review periods
• All other duties as assigned

The Candidate:

• Bachelor’s Degree is required
• Requires at least ten years of experience working in Quality areas in the Pharmaceutical industry with management responsibilities
• Full understanding of FDA and cGMP regulations is required
• Prior work experience in a regulated environment is required
• Experience working in a cGMP management role with an understanding of compliance and associated regulations is required
• In-depth knowledge of Quality Assurance and Regulatory Affairs as applicable to the Pharmaceutical industry is preferred
• 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 of PTO + 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

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