Director of Quality

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. The Role Ensure the Quality function complies with Health, Safety and Environmental requirements and employees adhere to the “Standards of Business Conduct.” As a member of the site leadership team, ensure an effective Pharmaceutical Quality Management system is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated, and implemented throughout the organization. Determine, establish and maintain comprehensive systems that establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer requirements. Ensure that the site complies with the requirements of Good Manufacturing Practice. Manage the Quality budget and ensure that adequate resources are available for the function to meet its obligations. Liaise with other functions and departments within the Catalent Pharma Solutions organization on aspects of Quality and Compliance which impact products, projects or the supply chain. Continuously review the operation of the quality function on site, provide best practice and deliver a program of continuous improvements that result in measurable operating benefits. Other duties as assigned. The Candidate Bachelor’s Degree in Chemistry, Biology or related scientific field required. Master’s degree in Chemistry, Biology or related scientific field preferred. Minimum of ten years’ experience leading a customer‑focused quality function including Quality Assurance, Quality Control and batch release within a pharmaceutical GMP environment required. Leadership experience supervising a team of managers/supervisors and analysts, scientists, and quality specialists. Demonstrated knowledge of International Quality and Compliance standards and requirements, with preferable FDA experience. Demonstrated knowledge of Change Management and Lean principles. Participated in managing and fronting regulatory inspections from both EU and US regulatory agencies such as MHRA, FDA, USDA. Ability to work under pressure to meet tight and changing deadlines. Assertiveness to ensure appropriate GMP and business standards are achieved. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs) may be considered in place of external experience. Benefits Comprehensive benefit package (Health, Dental, Vision, & Life Insurance). Group retirement savings – Registered Pension Plan (RPP) with employer contributions. Paid Time Off Programs including vacation, banked time, and personal time. Employee reward and recognition programs. Opportunities for professional and personal development. The anticipated salary range for this position in Massachusetts is $168,750–$257,800. The final salary offered may vary based on factors such as experience, education, and business needs. 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, please email the request to View email address on click.appcast.io including the job number, title, and location. Your request will be processed by a U.S. Catalent employee and routed to a local recruiter to ensure appropriate consideration. #J-18808-Ljbffr Catalent