Leading contract research and manufacturing organization serving the pharmaceutical and biotechnology industries seeks senior level Quality professional to direct Quality Assurance and Quality Control functions. The Director will ensure company implementation and adherence to regulatory and quality policies and standards, as well as, drive 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/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 and external customers to constantly achieve quality and business goals.
B.S./B.A. degree in Chemistry or related field and fifteen (15) plus years work experience in the pharmaceutical/biopharmaceutical industries, serving in both QA/QC positions or roles.
Extensive experience including supervising QA/QC staff, managing quality initiatives/improvement efforts, and conducting audits and inspections.
Strong understanding and knowledge of QC analytical techniques and industry regulations applicable to Life Science manufacturers.
Effective management, interpersonal, analytical and technical skills to identify and resolve operational issues and facilitate attaining company goals.
Our client is a global provider with a diverse portfolio of drug discovery programs and commercial products across nine countries offering an attractive learning and growth environment and generous rewards. Open to all candidate locations and offering relocation assistance. Please contact Tony Roig at [email protected] or 267-880-9416 for details.