Associate Director, Quality Control - Durham, United States - bioMérieux SA

Description

Position Summary:
The Associate Director, Quality Control provides direct oversight and guidance in the quality control laboratories including all science, technology and operations support for product testing areas to ensure bioMérieux manufactured products are appropriately measured and monitored according to quality system requirements (e.g., QSR and ISO9001/ISO This position works closely with other quality, industrialization, research & development, manufacturing, supply chain, purchasing and engineering departments.

Primary Responsibilities:

Leadership:
Models the principles and behaviors of bioMérieux and ensures personnel follow the company code of conduct.
Guides strategy implementation and oversees/monitors progress against team objectives which align with company and site objectives.
Manages and develops personnel.
Interacts in a positive and professional manner with colleagues, direct reports, internal departments, contractors, vendors and consultants.


Testing:

Responsible for ensuring the timely and efficient scheduling of raw material, intermediates, environmental monitoring, stability sample and finished goods testing requests submitted to the QC department.

Works collaboratively with other bioMérieux departments to ensure the testing and services provided to the site are developed, tested and delivered according to established procedures and regulations.

Ensures testing is performed on laboratory instrumentation that is appropriately validated, maintained, calibrated and monitored for compliance with procedures, regulatory and GLP requirements.

Demonstrates subject matter expert knowledge when troubleshooting laboratory issues related to assays, methods, instruments, and equipment.

Provides guidance on potential corrective and/or preventive actions and follows up to make sure actions are implemented within the laboratory.

Performs periodic GMP reviews of test data to ensure that test results meet all specifications. Works with laboratory managers to analyze trends in order to proactively mitigate equipment and reagent performance issues. Confirms QC laboratory managers are proactively monitoring laboratory equipment and associated equipment logs to ensure proper operation.


Laboratory Supplies:

Accountable for ensuring laboratory personnel are maintaining QC department laboratory supply needs and ordering/stocking supplies in a timely, efficient and cost effective manner.

Actively monitors the QC department laboratory supplies/equipment budget and proactively communicates issues that affect budget adherence.

Advocates for the purchase of new laboratory equipment/software as appropriate, striving to establish/maintain state of the art QC laboratory testing.

Quality:
The Associate Director, Quality Control is accountable for maintaining internal quality standards for QC department testing and documentation. They are responsible for the functioning of the QC laboratories in compliance with SOPs, GLP, GMP, and HSE requirements.
Executes laboratory, non-conformance and CAPA investigations in compliance with procedures. Provides input for laboratory investigations and communicates invalid test results cross-functionally.


Documentation/Training:

Ensures QC laboratory managers are training and mentoring laboratory personnel on Biochemistry, Microbiology and EM laboratory techniques, testing, documentation, data entry, processes and procedures.

Responsible for making sure the overall QC department training is maintained to current department processes, procedures and regulatory requirements.
Authors, reviews and approves new standard operating procedures (SOPs). Performs SOP revisions, reviews and approvals for existing QC department SOPs. Facilitates SOP implementation and training.

Verifies laboratory managers are conducting regular reviews of laboratory paper-based testing documentation and data entry into electronic systems (LIMS) to confirm compliance with procedures, GLP and GDP requirements.

Safety:
Ensures QC department personnel comply with all safety policies and procedures at all times.
Performs safety audits of the QC department laboratories and facilitates activities to address audit findings.


Continuous Improvement:
Identifies areas of deficiency and implements practices to improve employee safety, ergonomics, poor workflow, etc.

Recommends and implements process improvements which result in outcomes such as: improved QC testing quality, decreased operational costs, testing efficiency and and/or laboratory productivity.

Other Duties:

Ensures the QC department works collaboratively with other departments and assists with executing validation protocols associated with microbiology and biochemistry laboratory equipment, associated software and procedures including revalidation as scheduled/or required to maintain systems in a validated state.

Performs additional job-related duties as assigned by leadership to support business needs.


Education, Skills, & Experience:

BS/BA in Microbiology, Biology, Biochemistry or scientific field with 5+t years of experience in a related industry, with a minimum of 3+ years of supervisory experience.

Project management, performance on cross-functional project teams and indirect management experience will be considered in lieu of direct supervisory experience.

Academic experience will be considered in lieu of related industry experience.
Experience in supporting regulatory audits (i.e. FDA, MDSAP, ISO).
Able to demonstrate experience in the interpretation and application of relevant domestic and international regulations and industry standards (e.g. ISO, FDA, MDSAP, OSHA, EPA).

In depth technical and scientific knowledge with a demonstrated working knowledge of relevant biochemistry and microbiology laboratory techniques, including quality principles (GMP/GLP).

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