Director, Quality
Leading research and manufacturing organization serving the pharmaceutical and biotechnology industries seeks senior level Quality Manager to direct Quality Assurance and Quality Control function. The Director, Quality ensures company implementation and adherence to regulatory and quality policies and standards, as well as, drives quality improvement activities based on industry best practices while maintaining a company quality culture. Responsibilities include:
- Lead the Quality Assurance (QA) and Quality Control (QC) functions including the disposition of GMP materials, managing staff, and overseeing/assisting diverse Quality activities training/auditing programs, SOPs/Policies, investigations/validations, specifications/methods review, supplier qualifications etc.
- Serve as key resource on Quality initiatives, process improvement efforts, regulatory and client inspections/audits and partner with stakeholders to promote and maintain a quality culture.
- Establish and maintain quality systems and inspection-readiness programs that meet Quality standards/policies and facilitate operational excellence.
- Develop, monitor and report on quality performance and partner with internal/external customers to constantly achieve quality and business goals.
Qualifications
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B.S./B.A. degree in Chemistry or related field and fifteen (15) plus years work experience in the pharmaceutical/biotech/medical device industries, serving in QA and QC positions and roles.
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Extensive experience including supervising QA/QC staff, managing quality initiatives/improvement efforts, and conducting audits/inspections.
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Strong understanding and knowledge of QC analytical techniques and industry regulations applicable to API manufacturers.
- Effective management, interpersonal, analytical and technical skills to identify and resolve operational issues and facilitate attaining company goals.
Our client, a global provider with a diverse portfolio of drug discovery programs and commercial products across nine countries, offers an attractive compensation/package. Successful candidate will need to work at the facility near Albany, NY. Company will provide relocation assistance.
