Anu Bhatnagar
Director Quality Assurance, Lab Compliance @Novavax
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WORK HISTORY
Director Quality Assurance, Lab Compliance @Novavax
Gaithersburg, MD, US
EDUCATION
Case Western Reserve University
Ph.D., Biochemistry
Case Western Reserve University
Doctor of Philosophy - PhD
ABOUT ANU BHATNAGAR
Experienced strategic leader with expertise in Product Quality and Compliance with roles ranging with Quality Engineering, Quality assurance, Quality Operations, and laboratory compliance. Continuously delivering as a consultative leader and subject matter expert for diverse portfolio new product development activities (Biologics/Biosimilars, Vaccines, Devices). In-depth understanding on Global regulations enabling business with successful inspections and timely launches. Proven experience in building and fostering an innovative science and risk-based Quality culture. Strong expertise in working with internal manufacturing and CMOs globally. Passionate about transforming and cultivating a culture of quality and shared accountability ensuring compliance with applicable global regulations and corporate QMS.Quality Management* Biologics/Biosimilars* Vaccines* Biotechnology* Devices* Combination Products* Regulatory Inspection Readiness/Inspections* Health authority responses* GXP* CMO* Coaching/mentoring* Talent Development* Academia* Leadership*
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