Director of Quality

About the role

The Director of Quality at Catalent Pharma Solutions in Chelsea, MA will lead the Quality Assurance and Laboratory teams, ensuring compliance with Health, Safety and Environmental requirements and adherence to the "Standards of Business Conduct". They will oversee the implementation and maintenance of Quality standards and requirements, ensuring compliance with Good Manufacturing Practice (GMP), and will manage the Quality budget to ensure adequate resources are available.

Responsibilities

• Support site operations and the corporate Quality function
• Ensure an effective Pharmaceutical Quality Management system is in place, adequately resourced, and 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 compliance with requirements of Good Manufacturing Practice
• Manage the Quality budget and ensure 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 impacting products, projects, or the supply chain
• Continually review the operation of the quality function, providing best practice and delivering a program of continuous improvements to methodologies/systems employed resulting in measurable operating benefits

Requirements

• Bachelor’s Degree in Chemistry, Biology or related scientific field required
• Master’s degree in Chemistry, Biology or related scientific field preferred
• A minimum of ten (10) years’ experience of 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
• Demonstrate knowledge of International Quality and Compliance standards and requirements, with preferable FDA experience
• Demonstrated knowledge of Change management and Lean principals
• 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
• Ability to be assertive 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 such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Qualifications

• 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 (10) years’ experience of 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 principals
• Participation 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
• Ability to be assertive 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 such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Skills

• Knowledge of International Quality and Compliance standards and requirements, with preferable FDA experience
• Change management and Lean principals
• Experience 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
• Ability to be assertive to ensure appropriate GMP and business standards are achieved

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

Pay

The anticipated salary range for this position in Massachusetts is $168,750-$257,800. 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.

Schedule

Full-time position