Meenakshee Mishra
Sr Program Manager Director @American Regent, Inc.
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WORK HISTORY
Sr Program Manager Director @American Regent, Inc.
Leads the American Regent’s Quality Assurance, Quality Control and Sterility Assurance activities for the New York sites. Oversees GxP compliance initiatives and manage Quality Assurance, Quality Control and Sterility Assurance resources effectively, acting as Site Head of Quality. Partners with the Manufacturing Department to assure all standards, regulations and guidelines are followed in the manufacture of company products. Interacts with all areas and levels of the company in addition to regulatory agencies, vendors, consultants, and other intended parties. Currently managing Chemical Lab, Particles Lab, EM Lab and Micro Lab.
EDUCATION
Bhagalpur University
Bachelor's degree, Chemistry
New York University
Diploma, Computer Science
ABOUT MEENAKSHEE MISHRA
I am an accomplished, results-driven, innovative leader with expertise in QA Project/Program Management, thought leadership, and mentoring skills with over 15 years of experience in Pharmaceutical, Medical Device Manufacturing/Biomedical, HealthCare, and Financial Industries. I have designed and developed the QA Test from the beginning of the Business Simulation Test from the Scenarios of the User stories/Requirements to Production readiness Test. I have also managed Systems in compliance with 21 CFR 820 and ISO 13485:2016, communication with regulatory bodies, conducting audits, and supporting compliant execution of quality-related processes. I am experienced in implementing and transferring the QMS into the organization and ensuring that it is lived in everyday life.I am highly proficient in Resource Planning, Budgeting, Risk Management, and Successful Stakeholder Management and highly experienced in diverse ERP Systems (SAP, ORACLE, PEOPLESOFT, and SIEBEL, etc.), Supply Chain Management, What sets me apart is my attention to detail, can-do attitude, and ability to problem solve promptly. The challenge of creating and bringing new ideas to the industry is gratifying. I am also highly skillful in recognizing potential problems, evaluating alternatives, and implementing solutions. I have excellent communicator with the ability to work well across diverse backgrounds and all corporate levels. I have expertise in steering multifunctional domains with highly reputed business establishments. My remarkable leadership and interpersonal skills let me communicate with upper management and team members. I am confident in delivering impeccable results through my dedication to handling multiple functions and activities under high-pressure environments & tight deadlines.Areas of Expertise: Strategic & Operations Planning Business Development Solution Selling Presentations Quality Assurance Management Process Improvement Cross Function Team Leadership Competitive Analysis Global Business Planning Training & Leadership Customer Service Problem Solving Strong Interpersonal Skills Analytical Skills Client Relationship Management Team Management Quality Systems and Standards
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