Director - Quality Control (Chemistry & Biology)
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POST DATE 9/6/2016
END DATE 12/19/2016
Career Connection Network
JOB DESCRIPTIONOur client is seeking a new Director as the previous employee in this role has been promoted into another position. The position will pay between $150K - $160K + bonus eligibility. Our client will offer a relocation package, as appropriate. This Global employer is based just outside of Buffalo, NY.
CANDIDATES MUST HAVE PHARMACEUTICAL EXPERIENCE, AS WELL AS MICROBIOLOGY AND CHEMISTRY!
Oversee the testing of all products manufactured at the Grand Island manufacturing facility. Testing performed included IQC, raw material, In-Process, Finished Product and Stability Testing.
Direct the Stability program which included the testing, data analysis and FDS submission and annual report prep. This included the Product Development new product exhibit batches and commercial products.
Direct the equipment validation and analytical equipment calibration programs. Ensure the systems are robust and compliant with current industry practice and cGMP requirements.
Lead the Technical Services function. Provide support to manufacturing and quality control to resolve technical issues. Assure that the transfer of analytical technology from Product Development and external sources to manufacturing operations meets established and expected quality, regulatory and customer requirements.
Direct the process for monitoring USP compendial changes and assuring products are compliant with currant compendial standards.
Direct activities associated with evaluations or processes, results and risks. Drive development of continuous improvement plans, lead teams to execute continuous improvement projects and programs.
Accomplished Quality leader with relevant experience in injectable, aseptic pharmaceutical manufacturing operations.
* Significant quality manufacturing and management experience (10-15 years)
* Proven leadership ability in managing and leading multidisciplinary teams
* Proven experience in devising and leading change, results orientation and action bias
* Strong analytical problem solving experience is essential
* Demonstrate ability to troubleshoot and resolve complex technical and manufacturing problems
* Ability to effectively interact with and influence suppliers/vendors, regulators, global partners or affiliates, industry executives and trade organizations
* Bachelordegree with 12+ years of experience or Master's degree with 10+ years of experience or PhD with 8+ years of experience.