Kristine Caron
Chicopee,MA
Summary
Associate Director with extensive experience leading GMP operational quality and manufacturing quality systems within biologics/pharmaceutical environments. Proven track record driving deviation investigations, CAPA effectiveness, inspection readiness, and cross-functional collaboration with manufacturing, quality, and QC. Skilled in risk-based decision making, root cause analysis, and continuous improvement to ensure compliance with FDA and global regulatory standards. Strong leader known for building high-performing teams and delivering on quality and business objectives.
Overview
15
15
years of professional experience
Work History
Associate Director, Manufacturing QMS Lead
Sanofi Genzyme
Framingham, MA
07.2021 - Current
- Lead a team responsible for end-to-end deviation management, ensuring timely, compliant investigation closure.
- Serve as a key Operational Quality partner to Manufacturing, supporting batch disposition, investigations, and process improvements.
- Drive root cause analysis and CAPA development, ensuring effectiveness and alignment with regulatory expectations.
- Champion inspection readiness activities, including audit support, response preparation, and documentation compliance.
- Analyze and present quality metrics (KPIs) to leadership to identify trends, risks, and improvement opportunities.
- Lead cross-functional teams (Manufacturing, QC, QA) to resolve complex quality issues and enhance process robustness.
- Mentor and develop staff, fostering a culture of quality, accountability, and continuous improvement.
Principal Quality Engineer
Sanofi Genzyme
Framingham, MA
05.2014 - 07.2021
- Managed deviation investigations within TrackWise and Veeva systems, ensuring high-quality, compliant documentation.
- Led cross-functional investigations to identify root cause and implement sustainable CAPAs.
- Acted as interim manager supporting Manufacturing and Sample Management functions.
- Supported inspection readiness and audit activities, ensuring documentation and processes met global regulatory standards.
- Drove continuous improvement initiatives to enhance investigation quality and cycle time.
Manufacturing Specialist Supervisor
Sanofi Genzyme
Framingham, MA
03.2013 - 05.2014
- Supervised investigation workflows and ensured timely closure of deviations within GMP systems.
- Partnered with operations to resolve manufacturing issues and improve process performance.
- Led teams in root cause investigations and CAPA implementation.
Manufacturing Specialist III
Sanofi Genzyme
Framingham, MA
09.2011 - 03.2013
- Conducted and supported deviation investigations and CAPA execution.
- Collaborated with training and quality teams to enhance GMP training programs and compliance.
- Generated and presented quality metrics reports.
Education
MBA - Business Administration
University of Phoenix
Tempe, AZ05-2009
Bachelor of Science - Bioengineering
Western New England University
Springfield, MA05-1995
Skills
- GMP & cGMP Compliance
- Operational Quality Leadership
- Deviation & Investigation Management (TrackWise, Veeva)
- CAPA Strategy & Effectiveness
- Inspection Readiness & Audit Support
- Risk Management & Root Cause Analysis
- Cross-Functional Leadership
- Metrics, KPIs & Continuous Improvement
Timeline
Associate Director, Manufacturing QMS Lead
Sanofi Genzyme
07.2021 - Current
Principal Quality Engineer
Sanofi Genzyme
05.2014 - 07.2021
Manufacturing Specialist Supervisor
Sanofi Genzyme
03.2013 - 05.2014
Manufacturing Specialist III
Sanofi Genzyme
09.2011 - 03.2013
MBA - Business Administration
University of Phoenix
Bachelor of Science - Bioengineering
Western New England University