Suzy BAMBARA
Lausanne
Summary
Results-driven senior QA leader with over 20 years of international experience in the pharmaceutical and medical device sectors. Proven expertise in external vendor oversight for both small molecules and biologics across clinical and commercial stages. Adept at leading global teams, managing complex supply chains, and driving compliance with EU, US, ICH GMP/GDP & International regulations. Recognized for building high-performing teams, implementing robust quality systems, and fostering a culture of continuous improvement. Experienced in serialization, recall management, quality risk management, complaint management and inspection readiness across global markets
Overview
18
18
years of professional experience
Work History
Director QA, Global Commercial Distribution
Incyte Biosciences International
01.2023 - Current
- Lead QA strategy and execution for secondary packaging, and global commercial distribution for small molecules & biologics.
- Accountable for QA release of finished products worldwide, coordinating with QPs and ensuring timely market supply.
- Directed successful global product launches, including due diligence, distribution design, and packaging validation.
- Oversaw serialization compliance for EU and US; led investigations into counterfeiting and product quality complaints.
- Directed recall management activities, including execution of mock recall programs.
- Managed quality oversight of 60+ contractors (packaging, distribution, testing); led audit programs and performance reviews using risk-based tools.
- Directed Inspection Readiness Program for GDPs and GMPs; maintained full compliance during regulatory inspections.
- Partnered with cross-functional teams to enhance Incyte’s global eQMS and develop intercompany quality agreements.
- Member of operational leadership team, providing input on resource planning, performance metrics, and quality budget management.
Associate Director, Commercial QA
Incyte Biosciences International
02.2021 - 01.2024
- Hiring for expansion of the QA operations team in Switzerland, UK (as part of Brexit) and the US without disrupting team momentum
- Oversight of QA aspects pertaining to packaging, import testing and distribution activities worldwide (42 contractors)
- Qualified Person of Incyte Biosciences International Sàrl, in accordance with articles 5, 10, 14 and 15 of the Ordinance on Establishment Licenses
- Accountable for global finished product release, including coordination with EU QPs.
- QA lead for product launches: due diligence, distribution model design, packaging validation.
- Oversight of serialization in EU/US and secondary packaging CMOs & distribution hubs.
- Lead for critical quality processes: counterfeiting cases, complaints, returns, recalls (incl. mock recall program).
- Responsible for selection, auditing, and performance oversight of contractors (packaging, import testing, distribution).
- Drove Quality Risk Management and business reviews with CMOs.
- Led GDP/GMP Inspection Readiness Program and distribution risk management initiatives.
- Development of Intercompany Quality agreements supporting Global Supply Chain models
- Lead auditor for Partnerships, Packaging CMOs and Distribution Centers
- Established strong relationships with key stakeholders, creating mutually beneficial opportunities for growth and collaboration.
- Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
- Assisted senior leadership in managing all aspects of operations.
- Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
Sr. QA Operations Manager
Incyte Biosciences International
02.2019 - 03.2021
- Hiring and successful implementation of a team in both the US and Switerland
- Oversight of QA aspects pertaining to packaging, import testing and distribution activities worldwide
- Responsible for finished product release activity worldwide, including link with QPs
- QA Lead for global product launches: expert advice during supply model selection, due diligence audits, distribution model definition, and packaging validation.
- Managed serialization compliance in EU and US; led anti-counterfeiting investigations and follow-up.
- Oversaw product quality complaints, returns, and recall management (including mock recalls).
- Primary QA interface for secondary packaging CMOs and distribution hubs; led distribution risk management activities.
- Directed contractor qualification and audit programs for packaging, import testing, and distribution services.
- Conducted quality business reviews with CMOs; monitored performance using Quality Risk Management tools.
- Key contributor to the design and implementation of Incyte's electronic Quality Management System (eQMS).
- Management of the Inspection Readiness Program for GDPs/GMPs
- Development of Intercompany Quality agreements supporting Global Supply Chain models
- Lead auditor for Partnerships, Packaging CMOs and Distribution Centers
QA Operations Manager
Incyte Biosciences International
05.2016 - 01.2019
- Oversight of secondary packaging, distribution and GDP activities at affiliates in the EU
- Management of the QA relationship with the European Distribution centers network including change controls & inspection readiness programs
- Establishment and revisions of Quality Agreements with Distribution centers
- Responsible for QA release of commercial finished products in compliance with global GMP requirements.
- QA lead for recall management, including execution and oversight of mock recall programs.
- Management of distribution related events such as returns and deviations
- Coordination and maintenance of distribution risk management activities
- Management of the Quality Management Review program including planning, trending, reporting and action items follow up
- Management of the Incyte Biosciences International Quality Dashboards to ensure proper monitoring of Vendor Audits, Internal Audits, Changes, Deviations and CAPA
- Management of the Incyte Biosciences International Europe GDP/GMP training program including development and implementation of training plans training modules
- Lead auditor for Packaging CMOs and Distribution Centers
QA Operations Manager
Ariad Pharmaceuticals
03.2016 - 05.2016
- Oversight of the Quality Management System and GDP activities at Affiliates
- Management of the QA relationship with the European Distribution centers network including change controls
- Establishment and revisions of Quality Agreements with Distribution centers
- Management of distribution related events such as returns and deviations
- Coordination and maintenance of distribution risk management activities
- Management of the Quality Management Review program including planning, trending, reporting and action items follow up
- Management of the ARIAD Europe Quality Dashboards to ensure proper monitoring of Vendor Audits, Internal Audits, Changes, Deviations and CAPA
- Management of ARIAD Europe GDP/GMP training program including development and implementation of training plans training modules
- Interpretation of GDP, general regulatory requirements and Quality systems regulations for ARIAD Europe and maintain compliance of ARIAD Europe systems
- Inspection readiness programs with affiliates
QA Operations Sr Specialist
Ariad Pharmaceuticals
09.2015 - 02.2016
- Quality oversight of distribution centers
- Management of distribution related events such as returns and deviations
- Management of the Quality Management Review program including planning, trending, reporting and action items follow up
- Implementation and on-going monitoring of the ARIAD Europe Quality Dashboards to ensure proper monitoring of Vendor Audits, Internal Audits, Changes, Deviations and CAPA
- Management of the ARIAD Europe GDP/GMP training program including development and implementation of training plans training modules
- Lead auditor for Distribution Sites and GDP Internal Auditor at Affiliates
GxP Quality Systems Specialist
ARIAD Pharmaceuticals
05.2014 - 09.2015
- EQMS streamlining and redesign in line with company structure & product
- Maintenance of electronic data management system (training, CAPA, Deviations & documentation)
- Implementation of a Quality Management Review process to ensure systems effectiveness and continuous improvement
- Implementation of a training management process for all employees (planning, follow up and maintenance)
- Implementation KPI (Key Performance Indicators) and related follow up
- Implementation of an internal and external audit program
Quality Management Supervisor – Transcatheter Aortic Valve Implantation (TAVI) Program
Edwards Lifesciences
01.2011 - 06.2013
- Hiring & remote manager of a team based in the NL
- Participation in new product launches (before and after CE mark)
- QA lead for a Lean 6 Sigma project
- Adverse event reporting: participation in follow up meetings with the Clinical & Complaint Handling department
- Lead in the implementation of a training program for end customers. New valve replacement technology requiring extensive physician training to ensure proper valve sizing & positioning.
- Responsible for Quality Activities & Logistics
Senior Quality Specialist
Edwards Lifesciences
01.2010 - 12.2010
- Development of a supplier qualification process
- Implementation of a distributors management program
- Internal audits against international standards / internal processes (Professional Education group, Regulatory Affairs, Clinical Affairs and other CTQ processes)
- External audits (suppliers & distributors)
- Quality training to new employees
- Management of CAPA (Corrective and Preventive Actions) and FCA (Field Corrective Actions)
- Interaction with multi-disciplinary teams to execute competent authorities mandates
Quality Specialist
Edwards Lifesciences
06.2008 - 12.2009
- Implementation and maintenance of standard operating procedures in line with ISO13485
- Verification and validation activities
- Maintenance of a Retrospective Design History File, including design FMEAs and design reviews
- Management of internal and external audits
QA Coordinator in Design Control
Edwards Lifesciences
11.2007 - 05.2008
- Project lead for the implementation of a Device History File (DHF) against FDA CFR 820 requirements for a launch in the US of a hemofiltration device.
- Results: Successful launch within 6 months from project kick off.
Education
GenAI – Digital Strategies -
IMD School of Business
Lausanne, Switzerland01.2024
Green Belt - Lean & 6Sigma
Edwards Lifesciences
Nyon01.2013
Lead auditor - TUV IRCA Certificate
TUV
Paris01.2009
Master II Post Graduate Diploma - Quality Management
IAE of Tours
Tours01.2007
Master of Science - Business Management
University of Panthéon-Assas
Paris01.2006
Skills
- Versatile 20 Years’ experienced QA professional in both Medical Devices and Pharmaceutical industries
- Proven track record of successful achieving objectives, including those business critical
- Effectively built a team maintaining momentum & team spirit
- Proven expertise is Pharmaceutical GMPs & GDPs
- Excellent knowledge of standards and international requirements
- Proven track record of managing external partnerships in a dynamic environment
- GMP Compliance (EU, US, ICH)
- Quality Risk Management & QMS Development
- Regulatory Inspection Readiness (eg PAIs)
- Operational & Quality Excellence Initiatives
- Cross-functional Leadership & Change Management
- Strategic Budget & Resource Planning
ELECTRONIC SYSTEMS
- Veeva Vault, Pilgrim SmartSolve, Solabs, Stratas, TrackWise Digital, MasterControl
- Saba (electronic document & learning management system)
- Microsoft office, including MS Project and Visio
- Minitab & PDM (Product Data Management)
- SAP, JD Edwards
Timeline
Director QA, Global Commercial Distribution
Incyte Biosciences International
01.2023 - Current
Associate Director, Commercial QA
Incyte Biosciences International
02.2021 - 01.2024
Sr. QA Operations Manager
Incyte Biosciences International
02.2019 - 03.2021
QA Operations Manager
Incyte Biosciences International
05.2016 - 01.2019
QA Operations Manager
Ariad Pharmaceuticals
03.2016 - 05.2016
QA Operations Sr Specialist
Ariad Pharmaceuticals
09.2015 - 02.2016
GxP Quality Systems Specialist
ARIAD Pharmaceuticals
05.2014 - 09.2015
Quality Management Supervisor – Transcatheter Aortic Valve Implantation (TAVI) Program
Edwards Lifesciences
01.2011 - 06.2013
Senior Quality Specialist
Edwards Lifesciences
01.2010 - 12.2010
Quality Specialist
Edwards Lifesciences
06.2008 - 12.2009
QA Coordinator in Design Control
Edwards Lifesciences
11.2007 - 05.2008
GenAI – Digital Strategies -
IMD School of Business
Green Belt - Lean & 6Sigma
Edwards Lifesciences
Lead auditor - TUV IRCA Certificate
TUV
Master II Post Graduate Diploma - Quality Management
IAE of Tours
Master of Science - Business Management
University of Panthéon-Assas
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