Director of Quality

Catalent•Chelsea, MA

2d•$168,750 - $257,800

About The Position

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. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions in Chelsea, MA is hiring a Director of Quality who will provides leadership and daily management of the Catalent Boston Quality Department – Quality Assurance and Laboratory (Analytical Development/Quality Control). The responsibility of the role is to provide support to site operations as well as to the corporate Quality function. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

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, IBM, 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

Responsibilities

To 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;
To determine, establish and maintain comprehensive systems that establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer requirements;
To ensure that the site complies with requirements of Good Manufacturing Practice;
To manage the Quality budget and ensure that adequate resources are available for the function to meet its obligations;
To 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;
To continually review the operation of the quality function on site, to provide best practice and deliver a program of continuous improvements to the methodologies/systems employed which will result in measurable operating benefits;
Other duties as assigned.

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.

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