Catalent, Inc

Director, Quality

Princeton, NJ · Director

Sponsorship not specified$190k-$230kDetected 8 days ago

Clinical TrialsGMPLeadership

About the role

We have an opportunity for a Director, Quality to join our team.
This position oversees Quality Assurance and Quality Control and serves as the most responsible person for batch disposition.
You will also provide project guidance and work with customers to resolve quality concerns.

In this role, you will set the strategic direction for quality, ensure proper staffing, and maintain the Quality Management System to meet regulatory, corporate, and customer requirements.
You will lead site metrics, management reviews, and foster a Patient First culture.
Develop quality strategy, staffing plans, site quality metrics, and management reviews while fostering a patient-first culture.
Maintain regulatory and customer compliance across the site.
Manage audits, inspections, and remediation activities successfully.
Develop and execute the site Quality Plan and Quality Unit objectives.
Maintain and improve the Quality Management System.
Lead the site Quality function and Quality Management System to ensure compliance with regulatory, corporate, and customer requirements.
Partner with customers and internal teams to resolve quality issues and serve as a member of the Site Leadership Team.
Lead, develop, and manage Quality Assurance and Quality Control teams.

Bachelor's degree in chemistry, engineering, natural sciences, or related field.
10-12 years of pharmaceutical industry experience, including leadership roles.
Extensive knowledge of Quality Assurance and Quality Control.
Strong knowledge of current Good Manufacturing Practices (cGMP), International Council for Harmonisation (ICH), and global quality regulations.
Proven leadership of large, multi-level or multi-shift organizations.
Ability to solve problems and work independently with minimal supervision.
Experience with sterile drug product manufacturing.
Experience with drug substance manufacturing.
Experience with Cell Therapy.
Experience leading manufacturing site operations.

The anticipated salary range for this position in NJ is $190,000 - $230,000 Plus Bonus.
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.
Defined career path and annual performance review and feedback process.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

Serve as primary contact for customers and regulatory agencies.
Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent's cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium.

This listing is sourced directly from Catalent, Inc's careers page and normalized into a canonical job model.