Manager, Quality Assurance Operations

Manager Quality Assurance Operations

Position Summary:

• Work Schedule: Monday Friday 8:00am-5:00pm.
• 100% on-site

Catalent is a leading global CDMO trusted by pharma biotech and self-care companies to accelerate the development manufacturing and delivery of products that improve lives.

With advanced technologies deep expertise and a worldwide network we partner with innovators to transform bold ideas into life-changing therapies and self-care solutions.

Our U.S. commercial cell therapy manufacturing facility is located in Princeton NJ and is part of Catalents cell therapy network including our European Center of Excellence for cell therapy inGosselies Belgium.

The Manager Quality Assurance Operations Cell Therapy provides on-the-floor Quality Assurance (QA) oversight for GMP cell therapy manufacturing operations. This role ensures compliant execution review and disposition of manufacturing activities materials and documentation associated with clinical and commercial cell therapy products. Responsibilities include QA presence in processing areas batch record review lot disposition raw material release deviation management and direct support of aseptic and cell processing operations.

The Manager QA Operations reports to the Director Quality and may have direct reports including QA Specialists or Senior Specialists supporting manufacturing operations.

The Role:

• Provide realtime QA onthefloor support for cell therapy manufacturing operations including aseptic processing cell handling cryopreservation fill/finish and material handling activities.
• Perform GMP walkthroughs and observe critical manufacturing steps to ensure compliance with approved procedures batch records and Good Documentation Practices (GDP).
• Support manufacturing personnel during execution of complex or highrisk operations to ensure quality compliance and rightfirsttime execution.
• Review executed batch production records logbooks and associated GMP documentation for accuracy completeness and regulatory compliance.
• Support timely batch record review and participate in lot disposition and release decisions for clinical and commercial products.
• Perform QA review approval and release of raw materials consumables and critical reagents used in cell therapy processing.
• Review assess and approve deviations nonconformances investigations CAPAs and change controls impacting manufacturing operations facilities equipment or materials.
• Support supplier qualification activities materialrelated investigations and ensure material qualification documentation meets internal and regulatory requirements.
• Support inspection readiness activities and participate in regulatory inspections and client audits to ensure adherence to the Catalent Quality Management System (QMS) site SOPs and global standards.
• Provide daytoday leadership and QA guidance while collaborating crossfunctionally with Manufacturing Supply Chain MS&T Validation and Regulatory Affairs and supporting QA Operations training and development.
• Other duties as assigned.

The Candidate:

• Bachelors degree in Science Engineering or related discipline required; advanced degree preferred.
• Minimum of 7 years of experience in a GMP-regulated pharmaceutical biologics or cell/gene therapy manufacturing environment.
• Minimum of 3 years of Prior leadership or supervisory experience required with demonstrated ability to coach and manage performance.
• 5 years of Quality Assurance experience supporting manufacturing operations; direct QA on-the-floor experience required.
• Demonstrableleadershipexperience at Catalent (including but not limited to participation in Catalent-sponsoredleadershipprograms such as NGGL GOLD LEAD Now GM Excellence and GROW) may be considered in place of external experience.
• Demonstrated experience supporting GMP operations including batch record review lot disposition deviation investigations change control and work performed in manufacturing and cleanroom environments.
• Strong knowledge of GMP regulations and guidance including 21 CFR Parts 210/211 600series (biologics) applicable EU GMPs and ICH guidelines; cell therapy ATMP or aseptic processing experience strongly preferred.
• Experience with raw material qualification and release activities; supplier quality experience preferred.
• Strong written and verbal communication skills in English with the ability to work crossfunctionally under tight timelines manage multiple priorities with high attention to detail and willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test).

The anticipated salary range for this position in New Jersey is $130000 - $160000 plus annual bonus when eligible. The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job type and length of experience within the industry skillset education business needs etc. Catalent is a multi-state employer and this salary range may not reflect positions that work in other states.

Why you should Join Catalent:

• Defined career path and annual performance review and feedback process.
• Diverse inclusive culture.
• Potential for career growth on an expanding team.
• Cross-functional exposure to other areas within the organization.
• 152 hours of paid time off annually 8 paid holidays.
• Medical dental vision and 401K benefits effective day one of employment.
• Tuition Reimbursement.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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.

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