Provide quality oversight of outsourced GMP operations (CMC, CDMO, contract labs). Review and approve / reject policies, batch records, test methods, and change controls. Perform lot disposition of drug substances, products, and clinical materials. Support investigations, deviations, and CAPAs to ensure compliance. Assist with regulatory audits and vendor qualifications. Present quality metrics and drive continuous improvement initiatives. Requirements: Bachelor's degree in molecular biology, biochemistry, or related field (Master's preferred). 10+ years of QA management experience in biotechnology or medical devices. Strong knowledge of cGMPs, FDA, and international regulations. Excellent communication, organization, and mentoring skills. #J-18808-Ljbffr Lumicity
...distinguished regional network of ambulatory services. This 160,000 square foot expansion will continue to bring world-class academic medicine, cutting-edge technology, and innovative treatment options to the rapidly growing Doral community. UHealth at Doral will have...
...Job Description Job Description **We offer Year round work for our Fence Installers! Join Horizon Fence as a Full Time Fence Installer in South Portland, ME, and take your career to new heights! We are seeking experienced fence installers who are passionate about...
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Comcast brings together the best in media and technology. We drive innovation to create the world's best entertainment and online experiences. As a Fortune 50 leader, we set the pace in a variety of innovative and fascinating businesses and create career opportunities across...