Esha Gupta
Trumbull,CT
Summary
Dynamic Sr. Program Manager at NISSHA MEDICAL TECHNOLOGIES with a proven track record in strategic support and team leadership. Expert in data analysis, driving process improvements, and fostering stakeholder engagement. Successfully managed cross-functional teams to deliver projects on time and within budget, enhancing product quality and compliance in the medical device industry.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Sr. Program Manager
NISSHA MEDICAL TECHNOLOGIES
Wolcott, Connecticut
08.2022 - Current
- Responsible for directing and managing projects and product development from start to finish.
- Facilitates product development teams and establishes project plan.
- Works with authorized management representative to complete legal agreements as required for awarded projects.
- Procures product specifications from customer; communicates and transfers product specifications to the project/product development team.
- Manages cross-functional project teams during all phases of product development.
- Identifies and confers with project/product development team to outline work plan and to assign duties, responsibilities, and scope of authority.
- Directs the activities of project/product development team to review the function, performance, safety, statutory, critical to quality, and regulatory requirements of each project; works within QMS, FDA, and CE guidelines.
- Coordinates the activities of project/product development team members to ensure that the project progresses on schedule and within prescribed budget.
- Conducts design reviews with customer and internal design teams.
- Supports cost estimating and quoting through development process.
- Confers with project/product development team on product design for manufacturability.
- Manages project deliverables and milestones.
- Identify critical to quality requirements with customer and development team.
- Meets financial objectives by reporting monthly and yearly forecast requirements.
- Troubleshoots new and existing product problems; recommends solutions.
- Trains new program managers when necessary/delegated by manager.
QA Project Manager-Audits and Inspection Management
LONZA BIOLOGICS
Portsmouth, New Hampshire
08.2021 - 08.2022
- Responsible for supporting the implementation and execution of the Annual Quality and Internal Audit plans.
- Managed assigned activities to ensure timely closure of Quality Systems, and that compliance risks are communicated in a timely manner.
- Responsible for working with Site Leadership and customers to implement effective corrective and preventative actions in response to deficiencies.
- Responsible for actively pursuing opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance.
- Acted as a Lead Auditor or Co-Auditor in the planning and performance of assigned internal audits. as a part of audit planning, review recent trends and areas of concern, prepare audit checklists and the audit agenda.
- Lead projects, define project plan, scope, deliverables as assigned.
- Managed the backroom during customer audits, regulatory inspections and Lonza Global compliance audits.
- Liase with the site to fill front room requests from hosts.
- Acted as Front Room Host and Front Room Staff for the customer audits, regulatory inspections and Lonza Global compliance audits.
Program Manager
SQA SERVICES INC.
Rolling Hills, California
10.2015 - 08.2021
- Managed supplier audit and remediation programs for medical device, pharmaceutical, and semiconductor sectors.
- Led cross-functional teams to define critical requirements prior to program launches.
- Oversaw three Program Coordinators in planning and executing client audits to ensure compliance.
- Served as liaison between internal and external customers, facilitating effective communication.
- Analyzed Key Performance Indicators (KPIs) to identify improvement opportunities and validate changes.
- Supported customer audits, ensuring adherence to industry regulations for compliance.
- Developed work instructions for various tasks and coordinated associate training on procedures.
Senior Program Coordinator
SQA SERVICES INC.
Rolling Hills, California
07.2015 - 10.2015
- Company Overview: http://www.sqaservices.com/
- Recruited to return to the company, in an enhanced role, in preparation for promotion to Program Manager position. In this role, performed all functions as described for Program Coordinator. Assigned to a new client.
- Http://www.sqaservices.com/
Program Coordinator
SQA SERVICES INC.
Rolling Hills, California
10.2010 - 12.2012
- Facilitated auditor training and developed internal work instructions for client business processes.
- Finalized audit scopes for pharmaceutical and medical device companies, adhering to industry standards.
- Conducted technical training on STEPQ application via WebEx for new auditors and clients.
- Provided program administration resources for global quality improvement initiatives.
- Collaborated with Program Manager to coordinate client calls and discuss audit outcomes.
- Managed associate resource processes, focusing on continuous improvements in cost, time, and quality.
Education
Master of Science - Engineering Management
CALIFORNIA STATE UNIVERSITY
Long Beach, California01.2011
Bachelor of Technology - Electronics & Telecommunications
RAJASTHAN COLLEGE OF ENGINEERING FOR WOMEN
Jaipur, India01.2007
Skills
- Strategic support and recommendations
- Data analysis and insights
- Analytical skills and problem solving
- Partner development and collaboration
- Team management and leadership
- Process and operational improvement
- Executive presentations and communication
- Stakeholder engagement
Certification
- Certified Quality Engineer (CQE), 12/15/15
- Six Sigma Black Belt (CSSBB), 09/01/16
Projects
Toyota Production System, Provided extensive research on Toyota Production System – the final project for the Master of Science degree in Engineering Management., Spring 2011 Monogram Systems, Worked on a process improvement project as a part of MAE 511 Course (Quality Assurance in Manufacturing)., Carson, California, Spring 2009
Related Knowledge And Skills
- Strategic Support
- Data Analysis
- Recommendations
- Analytical Skills
- Partner Development
- Trackwise
- Team Management
- Process Improvement
- Operational Improvement
- Executive Presentations
- Problem Solving
- Stakeholder Collaboration
Timeline
Sr. Program Manager
NISSHA MEDICAL TECHNOLOGIES
08.2022 - Current
QA Project Manager-Audits and Inspection Management
LONZA BIOLOGICS
08.2021 - 08.2022
Program Manager
SQA SERVICES INC.
10.2015 - 08.2021
Senior Program Coordinator
SQA SERVICES INC.
07.2015 - 10.2015
Program Coordinator
SQA SERVICES INC.
10.2010 - 12.2012
Master of Science - Engineering Management
CALIFORNIA STATE UNIVERSITY
Bachelor of Technology - Electronics & Telecommunications
RAJASTHAN COLLEGE OF ENGINEERING FOR WOMEN
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