Overview
Director, Quality Control Jobs in Verona, Wisconsin, USA at Cedent Consulting
The purpose of this position within the Quality and Compliance department is to lead the Quality Control (QC) Laboratory consisting of analytical, microbial, stability, and reference standard quality control. This includes the establishment and optimization of processes, procedures, and analytical methods, ensuring our Quality Control (QC) aligns with business strategy and needs. Functions as the GMP laboratory testing technical consultant to QC staff and business operations per strategic business needs.
Responsibilities
Setting strategy, planning, coordinating, directing, coaching, developing, hiring, and planning the resources, facilities, and budgets to manage the QC laboratory including setting of vision and strategy, developing and managing operating budgets, management of technical employees, project management, and unit operational management.
Apply scientific and technological expertise to the validation and optimization of analytical techniques for the identification and characterization of molecules, oligo- and polynucleotides, and raw materials in cGMP compliant laboratories. Apply extensive advanced scientific knowledge to design and manage multi-disciplinary projects.
Provide leadership in product testing and Quality System to support overall business operations. Responsible for site processes and procedures related to the Quality Control laboratory to ensure product quality and compliance.
Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs and established timelines. Serves as an expert in technical/functional areas.
Apply advanced technical writing skills to prepare project protocols and reports to support product registration and/or business needs. Technical Reports and Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms).
Develop, negotiate, and finalize timelines and cost estimates for projects and/or service contracts to support business operations and/or external partner needs.
Represent the QC function during 3rd party, QP, and regulatory inspections at the Verona, WI facility.
Hiring and development of QC department staff at the Verona, WI.
Other duties consistent with the position as assigned from time to time.
Requirements:
Master’s Degree
10 years of experience in a GxP pharmaceutical/biotech company, contract manufacturing organization, or contract research
5 years of experience directing a QC laboratory in a cGMP facility.
Extensive knowledge of GMP and GDP regulations, as well as ICH/FDA guidance documents, including experience with the development of applicable compliance programs. Knowledge of GLP/GCP regulations.
Understanding of document control requirements in an FDA regulated environment.
Competent knowledge of and ability to use Microsoft Word and Excel.
Strong people leadership skills.
Solid understanding of financials and budgetary management experience.
Knowledge and understanding of the operation of product quality control lab, product quality control requirements, and systems.
Shows broad understanding of the issues relevant to the technical/science and business.
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Title: Director, Quality Control
Company: Cedent Consulting
Location: Verona, Wisconsin, USA
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
