Kristen Bouche
Waltham,MA
Summary
Proactive and goal-oriented QA professional with over 8 years of experience in Post-Market Quality Compliance and Business Analysis within the biotech industry, and 5 years experience as a Medical Lab Technologist. Recognized for reliability and adaptability, with a swift capacity to learn and apply new skills, driving team success and contributing to organizational growth. Demonstrates strong critical, analytical, and strategic thinking abilities, with a proven track record in project management, highlighted by leading data analysis initiatives using Tableau and Power BI, culminating in a prestigious CEO award. Proficient in FDA 21 CFR Part 820, ISO 13485, EU MDR, and MDSAP, with hands-on expertise in TrackWise, SAP CRM, Veeva, and eQMS. Adept at managing high-volume workloads in fast-paced, regulated environments while fostering collaboration and aligning team efforts with organizational objectives.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Regulatory and Compliance Specialist, QA
Dorel Juvenile
09.2025 - 12.2025
- Interpreting and applying regulatory policies to support product compliance.
- Make data-driven decision-making and strategic insights using Six sigma and Agile methodologies.
- Collaborate with internal teams to gather and communicate compliance requirements for new products.
- Maintenance of standard operating procedures and compliance documentation.
- Facilitate communication of updated regulatory requirements to both technical and non-technical stakeholders.
- Participate in compliance training and awareness initiatives across departments.
External Quality
Replimune
05.2025 - 06.2025
- Working under FDA 21 CFR 820 and ISO 13485 regulations, conducted batch record reviews.
- Led Continuous Improvement Product Complaint handling project.
Sr Associate I, QA Technical Product Complaints
Biogen
12.2020 - 10.2024
- Subject Matter Expert of the Quality Assurance Technical Product Complaints Compliance, Data Analytics, and Documentation team at Biogen.
- Conduct commercial and clinical complaint investigations and authored technically complex investigation reports.
- Collaboration with Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations and external Call Centers.
- Aligned with Compliance Standards creating, reviewing, and implementing EQMS and EDMS Documentation procedures and Annual Product Reviews.
- Initiated and oversaw data analysis projects, utilizing Power BI and Tableau.
- Supplier change notification, Change Control, and CAPA responsibility.
- CMO (Contract Manufacturing Organization) and third party manufacturing support.
- Performed process monitoring to evaluate product quality ensuring Product compliance.
- Define and present functional and technical requirements to both business and IT stakeholders using Six Sigma and Agile Methodologies.
Associate III, QA Technical Product Complaints
Biogen
12.2018 - 12.2020
- Experienced in Product Complaint Receipt including handling of sample return and coordinating investigations with CMOs via Trackwise and Salesforce.
- Facilitate the PC trending process, including metrics computation and quarterly report authoring.
- Data Analysis projects focused on Tableau and Power BI, which earned me a CEO award for KPI metric dashboard.
- Internal and FDA Regulatory audit experience, ensuring compliance in FDA 21CFR 820 and ISO 13485 and writing Annual Product Reviews per product.
- Experienced Trainer for Patient Services and New Hires.
Associate II, QA Technical Product Complaints
Biogen
03.2017 - 12.2018
- Conducted Product Complaint investigations (Deviation Review/CAPA) utilizing Trackwise and Salesforce systems and Triage safety Adverse event cases.
- Training SME both creating and conducting training sessions.
- Internal and FDA Regulatory audit experience, ensuring compliance in FDA 21CFR 820 and ISO 13485.
Associate I, QA Technical Product Complaints
Biogen
04.2015 - 03.2017
- Conducted Product Complaint handling in Trackwise and Salesforce databases and Triage safety Adverse event cases.
- Internal and FDA Regulatory audit experience, ensuring compliance in FDA 21CFR 820 and ISO 13485.
- Used critical thinking to break down problems, evaluate solutions, and make decisions.
QA/QI Specialist II
Dana Farber Cancer Institute
09.2014 - 04.2015
- Supported data analysis of clinical trials.
- Using Microsoft software to track Data and create presentations of results.
Medical Technologist
Lahey Clinic
12.2009 - 09.2014
- Medical Laboratory Technician specimen processor
- Experienced in Sterile technique
- Urinalysis and microscopic technique
- Performed STAT lab blood gas analysis and osmolality
- Maintained required laboratory supplies inventory, and verified viability of supplies prior to use.
- Analyzed laboratory findings to check accuracy of results.
- Participated in evaluation of new laboratory techniques, products and instruments.
- Enforced quality control protocols to maintain accuracy of test results.
- Trained and oriented new medical technologists to perform and interpret tests.
Education
Bachelor of Science -
Salve Regina University
Newport, RI05-2009
Associate of Applied Science - Medical Laboratory Science
Weber State University
Ogden, UT06.2014
Skills
- Quality Assurance
- Data analysis
- Regulatory
- Project management
- Documentation skills
- Power BI, Tableau
- SQL
- Investigation techniques
- Compliance monitoring
- Training Management Systems
- Trackwise, Veeva
- Salesforce
- Microsoft Office
- ISO 13485, FDA 21 CFR 820
- SAP
- Auditing processes
Certification
Medical Laboratory Technologist (MLT)
Timeline
Regulatory and Compliance Specialist, QA
Dorel Juvenile
09.2025 - 12.2025
External Quality
Replimune
05.2025 - 06.2025
Sr Associate I, QA Technical Product Complaints
Biogen
12.2020 - 10.2024
Associate III, QA Technical Product Complaints
Biogen
12.2018 - 12.2020
Associate II, QA Technical Product Complaints
Biogen
03.2017 - 12.2018
Associate I, QA Technical Product Complaints
Biogen
04.2015 - 03.2017
QA/QI Specialist II
Dana Farber Cancer Institute
09.2014 - 04.2015
Medical Technologist
Lahey Clinic
12.2009 - 09.2014
Bachelor of Science -
Salve Regina University
Associate of Applied Science - Medical Laboratory Science
Weber State University