Senior Quality Assurance & Manufacturing Leader
Resume:
Jean Claude Hakuzimana
https://www.linkedin.com/in/jean-claude-hakuzimana-472653186/ ****.******.**********@*****.***
Summary
A highly accomplished and results-driven Quality Assurance and Manufacturing Specialist with 15+ years of experience in diverse manufacturing environments, including pharmaceutical, medical device, and food industries. Proven expertise in developing and implementing quality management systems, ensuring compliance with QSR, ISO 9001, AS9100, and ISO 13485 standards. Adept at leading quality audits, managing CAPA and NCR processes, and driving continuous improvement initiatives. Strong leadership and communication skills with a focus on fostering collaborative and compliant work environments. Key Skills
• Quality Management Systems (QMS)
• QSR, ISO 9001, AS9100, ISO 13485
• CAPA, NCR, Root Cause Analysis
• Quality Audits and Inspections
• Process Validation
• GMP, GDP, GLP
• Document Control
• Change Control
• Training and Mentoring
• Cross-functional Team Leadership
• Inspection Equipment
• Machining Assembly Processes
• SAP, Veeva Vault, MES, LIMS
Professional Experience
Bristol Myers Squibb, Devens, MA
Senior-Field Quality Assurance Specialist (May 2023 - Present)
• Ensured compliance with federal requirements for GMP manufacturing (21 CFR 210, 211) and Quality Systems (21 CFR 820).
• Supported daily cGMP documentation management activities, including issuance and tracking of controlled documents and management of quality files using Veeva Vault. Jean Claude Hakuzimana
https://www.linkedin.com/in/jean-claude-hakuzimana-472653186/ ****.******.**********@*****.***
• Collaborated with cross-functional teams (Manufacturing, Supply Chain, Facilities, Process Science, Analytical Development) to ensure cGMP compliance.
• Authored and revised SOPs.
• Provided floor support for complex manufacturing activities, including electronic and paper batch record review.
• Conducted process validation and performance qualification, and calibration verification of drug product equipment.
• Performed walkthroughs of cGMP areas, documented observations, and supported return to service walkthroughs.
• Handled audits and followed up on client complaints.
• Assisted in authoring and revising Quality SOPs and provided quality review and approval of manufacturing-related SOPs.
Sanofi Pharmaceuticals, Framingham, MA
Documentation and Compliance Specialist (July 2022 - May 2023)
• Supported cGMP manufacturing operations through issuance of records and lot number assignment.
• Reviewed documents change requests for completeness, consistency, and compliance using the EDMS.
• Communicated with stakeholders to understand documentation needs and timelines.
• Managed document control room and archiving activities.
• Participated in internal and external audits.
Vertex Pharmaceuticals, Boston, MA.
Drug Manufacturing Senior Scientific Specialist (June 2021 - July 2022)
• Ensured compliance with federal requirements for GMP manufacturing (21 CFR 210, 211) and Quality Systems (21 CFR 820).
• Utilized SAP, MES, Trackwise, Veeva Vault, Qdocs, and LIMS.
• Supported Upstream, Downstream Processing and Clinical Injection Manufacturing teams.
• Conducted in-process troubleshooting, cleaning, sanitization, and validation of equipment and process rooms in a cGMP environment.
• Trained personnel in cGMP, GDP, and GLP.
Jean Claude Hakuzimana
https://www.linkedin.com/in/jean-claude-hakuzimana-472653186/ ****.******.**********@*****.***
State Garden Inc., Chelsea, MA
Quality Assurance Supervisor (October 2018 - January 2020)
• Oversaw quality assurance operations, including calibration and verification of equipment and inspection of facilities.
• Authored Standard Operating Procedures and developed detailed Work Instructions.
• Conducted random quality inspections on raw materials, in-process, and packaged products.
• Trained new personnel.
Previous Experience
• Proctor & Gamble
• Tyson Foods
• Spaulding Composites
• Falvey Linen & Supply
• John Deere
Education
Massachusetts Institute of Technology
Cambridge, MA.
Chief Product Officer Training
The University of Rhode Island
Kingston, RI
College of Engineering
Moses Brown School
Providence, RI
Jean Claude Hakuzimana
https://www.linkedin.com/in/jean-claude-hakuzimana-472653186/ ****.******.**********@*****.***
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