Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Jennifer Kapadia

Providence

Summary

Results-driven Associate Director of Quality Control with over 20 years of hands-on experience in quality control. Skilled in managing day-to-day operations of a quality control laboratory and overseeing personnel. Extensive expertise in quality control testing, cGMP laboratory operations, test methods, equipment validation, and various chemistry techniques. Proficient in utilizing instrumentation such as UV-Vis, GC, FTIR, DSC, TGA, viscometers, Karl Fischer, pH, and conductivity meters. Demonstrated strong analytical ability and in-depth knowledge of Pharmacopeia and ICH guidelines. Proven track record of leadership and team-building skills with a focus on driving continuous improvement through LEAN initiatives like 5S, Kaizen, and Value Stream Mapping.

Overview

26
26
years of professional experience

Work History

Associate Director, Quality Control

Vertex Pharmaceuticals - VCGT
08.2024 - Current
  • Lead a team of up to 16 personnel, overseeing the day-to-day activities related to the in-process and release testing of raw materials and final medical devices.
  • Oversee laboratory program(s)/processes such as Sample Receipt, equipment PM/calibration program, change control/investigations/deviations, and/or method validations.
  • Review, and/or approve data, SOPs, COAs, analytical methods, protocols, reports, OOS/OOT investigations and deviations. Ensure all laboratory records adhere to cGMP/GDP expectations.
  • Serve as QC representative in cross-functional, cross-departmental working teams and/or collaborating with outside vendors to meet all laboratory needs.
  • Establish and communicate KPI's and performance objectives for staff that are consistent with department, site, and company goals.
  • Foster a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
  • Foster a culture of Quality by implementing procedures, documentation and training in compliance with GMP and applicable regulatory requirements
  • Prioritize tasks and allocated resources appropriately to keep teams focused and productive.
  • Mentor junior staff members, providing guidance on professional development opportunities and career progression paths within the company.
  • Establish strong relationships with key industry partners, creating mutually beneficial opportunities for growth and collaboration.
  • Improve overall team efficiency by streamlining project management processes and implementing new collaboration tools.
  • Represent as department lead in lab audits
  • Oversee annual budget planning processes, ensuring financial goals were met while maintaining optimal resource allocation across departments.
  • Implement data-driven decision-making strategies, leading to more informed business choices and positive outcomes.
  • Leverage data and analytics to make informed decisions and drive business improvements.
  • Assist in organizing and overseeing assignments to drive operational excellence.
  • Evaluate employee performance and convey constructive feedback to improve skills.
  • Cultivate positive rapport with fellow employees to boost company morale and promote employee retention.

Senior Manager, Quality Control

Vertex Pharmaceuticals - VCGT
08.2022 - 08.2024
  • Provide oversight in the coordination, management, and prioritization of laboratory activities.
  • Work with internal and external partners to ensure laboratory activities are scheduled and prioritized to meet commitments on-time.
  • Created Tier board for improved communication within the team and across departments
  • Ensure all lab personnel have adequate training, education, and experience to perform their GMP related job function effectively.
  • Review, and/or approve data, SOPs, COAs, analytical methods, protocols, reports, OOS/OOT investigations and deviations.
  • Monitor, track and publish lab metrics for the department and take actions, as necessary.
  • Provide developmental feedback and coaching to direct reports to create a collaborative environment that attracts, develops, and retains personnel.
  • Ensure all laboratory records adhere to cGMP/GDP expectations.

Manager, Quality Control

Vertex Pharmaceuticals - VCGT
01.2021 - 08.2022
  • Collaborated with cross functions to build a GMP QC laboratory to meet on time lab readiness
  • Led planning, coordination and review of method validations, transfers and equipment qualifications.
  • Served as QC representative in cross-functional, cross-departmental working teams and collaborated with outside vendors to meet all laboratory needs.
  • Managed various laboratory program(s)/processes within the department and served as subject matter expert (SME)
  • Assisted in troubleshooting of analytical methods and equipment as required.
  • Authored, reviewed, and approved data, SOPs, COAs, analytical methods, protocols, and reports.
  • Monitored, tracked and published lab metrics.
  • Ensured all laboratory records adhere to cGMP/GDP expectations.

Quality Control Supervisor

Sanofi Genzyme
02.2012 - 11.2016
  • Managed all operations within the Quality Control laboratory.
  • Coordinated and scheduled all Quality Control product testing.
  • Selected, developed, and motivated qualified staff to effectively conduct department functions and provide regular performance feedback.
  • Provided leadership, guidance, and direction to staff consistent with cGMP, Quality Systems, and regulatory requirements.
  • Established and report on Department metrics, Key performance indicators and process driven goals.
  • Managed purchase orders and accruals to maintain within department budget.
  • Analyze, review and release data for In- Process testing, Final testing, and stability testing.
  • Alert of any significant quality, compliance, supply, and safety risks to next level management
  • Provide testing and analysis of investigation and validation samples.
  • Collaborate and Schedule required sample testing with other departments and contract labs.
  • Participate in daily interdepartmental meetings to help support day to day site operations.
  • Manage Equipment Qualifications, Method Assessments and Assay/Method Validations.
  • Approve and/or Author technical reports, validation reports and Standard operating procedures.
  • Perform and Manage Deviations/CAPAs /CCRs within the Trackwise database and help drive to closure.
  • Lead and participate in cross functional teams to find root cause for Deviations, OOS’s and Trends
  • Author and/or approve Lab Investigation Reports
  • Lead troubleshooting activities for assay, equipment, or testing issues.
  • Represented Quality Control in audits and responsible for Audit-Readiness of the group and lab.
  • Harvard Business School “Managing Others” Program – Completed September 2015
  • Team Member for Sepralap Product launch acting as Quality subject matter expert.

Quality Control Supervisor

Siemens Medical Solutions Diagnostics
05.2007 - 02.2012
  • Managed Quality Control production staff for the Infectious Disease Quality Control Group
  • Managed routine product manufacturing and testing to ensure that cost effectiveness, manufacturability, quality, and safety requirements are attainable in the production process.
  • Helped set Department metrics, Key performance indicators and establish process driven goals.
  • Coached and mentored staff in all areas of their job performance and career development, holding regular one on one discussions as well as Mid-year and Yearly reviews.
  • Analyzed and reviewed data for In- Process QC testing and Final QC testing for assays.
  • Worked with QC Micro group in testing and helping analyze bio burden results.
  • Performed investigations, deviation assessments, compiled data and presented on findings associated with these investigations.
  • Trained and supervised individuals of different skill levels.
  • Interacted with cross functional teams daily to help support day to day operations.
  • Held professional meetings to review data, update on product investigations / projects, and quarterly metric updates.
  • Reviewed trend data for Routine Stability Studies

QC Analyst I, II, III

Siemens Medical Solutions Diagnostics
12.1999 - 05.2007
  • Tested and compiled data for In- Process QC testing, final QC testing and data analysis for immunodiagnostic assays.
  • Performed New York State Survey testing and College of American Pathologists Survey testing.
  • Performed lab duties on various lab equipment.
  • Performed, trained, and coordinated Northern Blot Testing for HIV and HCV assays using radioactive isotope P32.
  • Special Recognition Award for Leadership – December 2004

Education

Bachelor of Science - Biology, Minor in Psychology

University of Rhode Island
Kingston, RI
05.1999

Skills

  • Project management
  • Strategic leadership
  • Analytical thinking
  • Coaching and mentoring
  • Decision-making
  • Team collaboration and leadership
  • Process improvement
  • MS office
  • Organizational development
  • Budget management
  • Operations management
  • Resources allocation

Accomplishments

Created GMP Quality Control laboratory in 2021 and hired a high functioning team.

Established a Second shift QC team to support manufacturing and testing needs


Timeline

Associate Director, Quality Control

Vertex Pharmaceuticals - VCGT
08.2024 - Current

Senior Manager, Quality Control

Vertex Pharmaceuticals - VCGT
08.2022 - 08.2024

Manager, Quality Control

Vertex Pharmaceuticals - VCGT
01.2021 - 08.2022

Quality Control Supervisor

Sanofi Genzyme
02.2012 - 11.2016

Quality Control Supervisor

Siemens Medical Solutions Diagnostics
05.2007 - 02.2012

QC Analyst I, II, III

Siemens Medical Solutions Diagnostics
12.1999 - 05.2007

Bachelor of Science - Biology, Minor in Psychology

University of Rhode Island

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