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Catalent · 3 days ago

Director, Quality

Kansas City, MO

Full-time

Onsite

Director/Executive

10+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to improving patient health. The Director of Quality will lead the quality unit, ensuring compliance with regulatory requirements and overseeing the Quality Management Systems to support product development and customer satisfaction.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit ensuring expectations are met consistently and at a high level

Develop and implement Site Quality Plan, Quality Unit objectives and related procedures

Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations

Monitor site compliance to FDA, EU and all other applicable requirements

Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated

Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner

Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records

Ensure that all necessary QC testing is performed on manufactured products supporting and meeting business objectives and on-time deliveries. Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures

Other duties as assigned

Qualification

Quality Management SystemsRegulatory complianceQuality assurance leadershipBiologics manufacturingCGMP knowledgeProject guidanceCustomer relationsTeam management

Required

Bachelor's Degree Required (scientific field preferred)

10+ years' experience in pharmaceutical industry with increasing levels of responsibility and leadership in quality assurance, compliance and quality control

Experience leading Quality Operations at a manufacturing site operation for 3 years at a minimum (e.g. Quality Operations, QC Operations, Manufacturing) is required

Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment

Must have a demonstrable record of implementing and maintaining a total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics

Proven ability to lead a large, multi-level/multi-shift organization (e.g. 50+ employees) effectively

Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments

Preferred

Master's Degree in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology preferred

Experience with Biologics / sterile drug product manufacturing is strongly preferred

Benefits

Defined career path and annual performance review and feedback process

Diverse, inclusive culture

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

Dynamic, fast-paced work environment

Community engagement and green initiatives

Generous 401K match and Paid Time Off accrual

Medical, dental and vision benefits effective day one of employment

Tuition Reimbursement

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)

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2022 (1)