Catalent, Inc

Director of Quality

Chelsea, MA · Director

Sponsorship not specified$169k-$258kDetected 9 days ago

Supply ChainClinical TrialsGMPFDA RegulatoryLeadershipGxP

About the role

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 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 manage the Quality budget and ensure that adequate resources are available for the function to meet its obligations;
To determine, establish and maintain comprehensive systems that establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer requirements;
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.
The responsibility of the role is to provide support to site operations as well as to the corporate Quality function.

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;

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.

Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply.
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.

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