Director, Quality

Position Summary

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Our Princeton, NJ site is part of Catalent's cell therapy network. 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 Director, Quality is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to ensure the site is in compliance with regulatory, Corporate, and customer requirements. This role is responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality is responsible for both Quality Assurance and Quality Control. This individual is the most responsible person for batch disposition, is responsible for providing project guidance/support, and will work with customers to resolve quality concerns as appropriate.

The Role

• Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.
• Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.
• Monitor site compliance to FDA, EU and all other applicable requirements. Interface with all other departments to ensure compliance with cGMP.
• Ensure site procedures align with Corporate policies.
• Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to ensure the department remains engaged and motivated.
• Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner. Analyze, resolve, or assist in solving compliance and customer issues.
• Prepare, approve, and manage Quality departmental budget.
• Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records.
• Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures.
• Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required.
• All other duties as assigned.
  
  
  

The Candidate

• Bachelor’s degree in chemistry or closely related field (e.g. natural sciences, engineering)
• 10-12 years’ directly related experience in pharmaceutical fields including managerial roles
• Experience with sterile drug product manufacturing and drug substance manufacturing is strongly preferred. Experience with Cell Therapy is preferred
• Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred
• Ability to work in a start-up business and have the mindset of growth
• Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments
• 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
  
  
  

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 within an organization dedicated to preserving and bettering lives
• Dynamic, fast-paced work environment.
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision 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 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.

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