Director of Quality

Director of Quality Director of Quality at Catalent Pharma Solutions (Chelsea, MA) will provide leadership and daily management of the Catalent Boston Quality Department – Quality Assurance and Laboratory (Analytical Development/Quality Control). The role supports site operations and the corporate Quality function, ensuring a robust Pharmaceutical Quality Management system and compliance with regulatory and safety requirements. Key Responsibilities Ensure the Quality function complies with Health, Safety and Environmental requirements and employees adhere to the “Standards of Business Conduct”. Serve as a member of the site leadership team to maintain an effective Pharmaceutical Quality Management system that is adequately resourced and whose roles, responsibilities and authorities are clearly defined, communicated and implemented throughout the organization. Determine, establish and maintain comprehensive systems that document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer expectations. Ensure compliance with Good Manufacturing Practice (GMP) requirements. Manage the Quality budget and ensure adequate resources are available to meet the function’s obligations. Liaise with other functions and departments within the Catalent Pharma Solutions organization on aspects of Quality and Compliance that impact products, projects or the supply chain. Continuously review the operation of the quality function on site, provide best practice and deliver continuous improvements to the methodologies and systems employed, producing measurable operating benefits. Perform additional duties as assigned. Qualifications Bachelor’s Degree in Chemistry, Biology or a related scientific field (required). Master’s Degree in Chemistry, Biology or a related scientific field (preferred). Minimum of ten (10) years’ experience leading a customer‑focused quality function—including Quality Assurance, Quality Control and batch release—in a pharmaceutical GMP environment. Leadership experience supervising managers/supervisors, scientists, analysts and quality specialists. Knowledge of International Quality and Compliance standards; FDA experience preferred. Knowledge of change management and Lean principles. Experience managing and fronting regulatory inspections from EU and US agencies (e.g., MHRA, IBM, FDA, USDA). Ability to work under pressure to meet tight and changing deadlines. Assertiveness to ensure appropriate GMP and business standards are achieved. In‑house leadership experience at Catalent (e.g., participation in NGGL, GOLD, LEAD Now, GM Excellence, GROW) may be considered in place of external experience. Salary Range (Massachusetts): $168,750 – $257,800. Final offer will depend on experience, education and business needs. Equal Opportunity & Accommodation Statement Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation during the application or hiring process due to a disability, please contact View email address on click.appcast.io with the job number, title and location. #J-18808-Ljbffr Catalent Pharma Solutions