Pinaki Chakraborty
Vice President, Quality Assurance @Quantum Leap Healthcare Collaborative
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WORK HISTORY
Vice President, Quality Assurance @Quantum Leap Healthcare Collaborative
San Francisco, CA, US
Vice President of Quality Assurance for the innovative Quantum Leap I-SPY breast cancer neoadjuvant treatment trials, I-SPY COVID treatment trials to reduce mortality and other projects, developing new treatments faster and for less. QLHC is a collaboration between medical researchers at University of California, San Francisco (UCSF) and Silicon Valley entrepreneurs across the medical, technology and bioscience industries to integrate high-impact research with clinical processes and systems technology to improve and save lives.
EDUCATION
University of Miami
Ph.D., Industrial Engineering (Concentration - Manufacturing Systems)
University of Florida - Warrington College of Business
MBA, Business Administration and Management, General
University of Miami
M.S., Industrial Engineering
Birla Institute of Technology, Mesra
B.S., Mechanical Engineering
SKILLS
ABOUT PINAKI CHAKRABORTY
High-performance Quality/Regulatory Executive with talent for making complicated things simple. Proven track record of leading breakthrough improvements in quality systems, compliance, and external audit performance. Examples of major accomplishments:1. Completed validation remediation and got a Fortune 500 medical device company out of FDA warning letter trouble2. Optimized a document management system to make it more lean and efficient with significant cost savings3. Successful quality system transfer of a $300 Million revenue FDA Class II and Class medical device manufacturing plant from US to Costa Rica in 2 years 4. Executed a quality system turnaround at a Fortune 500 company with zero FDA and notified body audit findings5. Built a ISO 14•••••12 compliant risk management system ground up that incorporated usability analysis 6. Successfully led MDSAP/EN ISO 13•••••16 transition program at a Fortune 500 firm7. Succesfully headed compliance program at a Fortune 500 acquisition site with good compliance record8. Successfully lifted two Warning Letters at the World\'s largest medical research organization (MRO) Well versed with 21 CFR 820, cGMP regulations, ISO 13•••••16, MDSAP, JPAL, ANVISA, CMDCAS, EU MDD/MDR, GLP, GCP, ISO 17025, and other global regulations. Experience covers the areas of Quality assurance, Quality systems, Manufacturing/Manufacturing Systems, Program Management, New Product Development, Pre-Clinical and Clinical (CRO). Strong people leadership skills. Competencies are listed below:•ISO 13•••••16/MDSAP Certified Lead Auditor•ISO 14971 Risk Management•GLP•GCP•Design Controls•FDA Warning Letter Remediation •M&A due diligence•Business Process Re-engineering•Project Management (PMP)•Manufacturing Plant Transfer•CAPA/Post Market Surveillance/Complaint handling•Process/Test method validation •Supplier Controls•Lean Manufacturing•Six Sigma Problem Solving
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