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Senior Director, Quality Control

Company: LFB USA, Inc.
Location: Framingham
Posted on: September 12, 2020

Job Description:

The Senior Director of Quality Control is responsible for managing QC and validation functions across all product lines. Oversees Microbiology, Raw Materials, Stabillity and Analytical labs. Also responsible for ensuring successful and timely completion of deliverables addressed during project execution. Requires considerable judgment and skills to identify and rectify test method problems and make recommendations for corrective action necessary to assure conformity with Quality specifications. This position works closely Operations, Quality Assurance and Regulatory Affairs to develop and maintain a comprehensive program that assures consistent quality throughout the production platform .

Responsibilities Responsible for internal and external quality testing; ensures complete documentation for compliance with cGMPs.

Oversees QC group leaders and staff as appropriate. Supports QC organization during release, stability, and in-process testing, and inspections and audits of the QC organization.

Oversees equipment maintenance and calibration, and laboratory maintenance. May be involved in laboratory design.

Oversees GMP material control program including, material management, inventory, lot release and control.

Oversees programs including Assay Control, Reference Standard and OOS.

Serves as a member of the quality management team and provides both management and leadership to a team of technical professionals and administrative staff.

Develops QC budget including defining materials, equipment and personnel needs.

Provides long-term planning of QC lab capabilities and capacity. Responsible for the implementation of new technologies.

Signature authority for all Quality Control documents and data, including Certificates of Analysis.

Active participant in the management and direction of the overall corporate Quality Program as it relates to internal and external programs and requirements.

Qualifications PhD (preferred) in a scientific discipline with a minimum of 10 years management experience in a GMP regulated industry; biotechnology, pharmaceutical.

Excellent leadership skills required to head a QC team of technical professionals which includes; microbiology, raw materials and stability.

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Keywords: LFB USA, Inc., Framingham , Senior Director, Quality Control, Other , Framingham, Massachusetts

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