Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07274 About our client Our client is a leading biotechnology/pharmaceutical company. Position Location Quality Control Director MA Salary Highly competitive package, commensurate with experience Responsibilities Partial Job Description 1) Direct the management of Chemistry, Microbiology and Physical Testing labs 2) Establish and promote an environment conducive to continuous quality improvement 3) Drive quality initiatives and achieve established goals across all manufacturing areas and within the organization 4) Lead product and process improvement projects, revising processes and procedures as required ensuring timely execution 5) Establish a failure analysis system to troubleshoot quality issues including incoming materials failure analysis and root cause analysis to avoid re-occurrence 6) Adhere to all quality regulations, including preparation for and response to internal and external quality audits 7) Act as a cross-functional team facilitator during methods troubleshooting 8) Develop and report on metrics for overall quality standards and provide vendor analysis and implement corrective action as needed 9) Develop and execute a Lab Validation Master Plan 10) Provide leadership direction to support changing business priorities and initiatives Requirements Qualifications / Skills Required 1) Advanced degree in a related Scientific discipline 2) 10+ years of experience in the pharmaceutical industry or related GMP environments, including 5 years in Quality laboratory staffing and project management 3) Demonstrated hands-on laboratory knowledge including cGMP, GLP, and Part 11 among others 4) Strong knowledge of domestic and international regulations and USP, EP and Japanese standards experience 5) Previous experience working cross-functionally within both Chemistry and Microbiology areas and with radioactive materials preferred 6) Strong experience in method development as well as for method transfer 7) ANSI sampling experience 8) Ability to direct laboratory quality responses by interacting with cross-functional teams within the organization 9) Flexibility is required to work with changing priorities, at times redirecting resources to meet business demands 10) Solid communication and technical writing skills 11) Proficiency in computerized systems and applications
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