Senior Specialist, Quality Operations

Senior Specialist Quality 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 CGMP manufacturing facility is equipped with 16 flexible clean rooms QC labs and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production.

The Senior Specialist Quality Operations candidate provides Quality advanced oversight and guidance for all programs in support of GMP Manufacturing of Cell Therapy products at our US Cell Therapy facility located in Princeton this role youll lead the development and management of Quality Systems ensure compliance with regulations and support audits and inspections. Youll serve as the dedicated Client QA Representative partnering with cross-functional teamsManufacturing Process Development Technology Transfer and moreto maintain site compliance and drive continuous improvement.

The Senior Specialist Quality Operations will report to the Director Quality.

The Role:

• Provide advanced QA oversight for GMP documentation batch record review and compliance activities.
• Lead development and management of Quality Systems including change control risk management and supplier qualification.
• Support and manage investigations (OOS deviations) CAPAs and engineering change requests.
• Review and approve validation protocols COAs/COCs calibration and maintenance records for completeness.
• Compile track and present quality metrics for batch release client projects and site compliance programs.
• Drive process improvements to reduce defects improve turnaround times and ensure timely batch disposition.
• Serve as dedicated QA liaison for client projects from initiation through closure including audits and meetings.
• Coordinate and facilitate risk assessments maintain site risk register and report to leadership.
• Author review and revise SOPs; conduct internal audits; and support external audits and inspections.
• Train new QA staff and contribute to Management Reviews and Annual Product Reviews.
• Other duties as assigned.

The Candidate:

• Bachelor of Science degree required preferably in a Life Sciences discipline; Master of Science degree preferred.
• Minimum of 7 years experience within the biologic biopharmaceutical or regulated industry.
• Experience performing cGMP internal audits and/or supplier audits. Auditor certification (CQA or equivalent) is a plus.
• Cross-site inter and intra departmental project management experience and experience with electronic document management systems desired.
• Proficient in GMP regulations batch record review and batch disposition processes with ability to apply scientific and regulatory principles to resolve operational and quality challenges.
• Experience with Risk Management and Good Manufacturing Practices (GMPs) 21 CFR Parts 210 211 biological regulations per 21 CFR Parts 600s ICH Guidelines and EU GMPs.
• Proficient with biological manufacturing processes including cell banking microbial/cell culture fermentation purification and fill/finish.
• Strong communication skills (verbal written oral) proven ability to work independently and collaboratively prioritize tasks and apply problem-solving skills in a fast-paced GMP environment.

The anticipated salary range for this position in New Jersey is $110000 - $125000 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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