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Catalent · 23 hours ago

Director of Quality

Chelsea, MA

Full-time

Onsite

Director/Executive

$169K/yr - $258K/yr

10+ years exp

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 Director of Quality will provide leadership and daily management of the Quality Department, ensuring compliance with quality standards and supporting site operations.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

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

Qualification

Quality AssuranceQuality ControlPharmaceutical GMPRegulatory InspectionsInternational Quality StandardsLeadership experienceChange managementLean principlesAssertivenessTeam supervision

Required

Bachelor's Degree in Chemistry, Biology or related scientific field required

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

Preferred

Master's degree in Chemistry, Biology or related scientific field preferred

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

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.

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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2022 (1)