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
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
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
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
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