Giulia Sapuppo
Neuchâtel
Summary
Results-driven management professional with track record of optimizing team performance and driving business growth. Skilled in strategic planning, project management, and fostering collaborative environments. Known for adaptability and delivering consistent results in dynamic settings. Strong focus on leadership, problem-solving, and effective communication.
Overview
3
3
Languages
16
16
years of professional experience
Work History
Associate Manager MSIT Validation
J&J Innovative Medicine
Bern, Switzerland
01.2024 - 01.2026
- Managed lifecycle validation activities by overseeing a team of 10, maintaining compliance with established strategic goals and GMP regulations.
- Achieved streamlined validation processes through effective authorship and approval of validation plans and protocols. Enhanced risk assessment accuracy and compliance with technical and GMP documentation standards.
- Led cross-functional teams to implement process improvements in product development cycles.
- Developed and executed strategic operational plans to enhance efficiency across departments.
- Facilitated collaboration with multi-functional teams to ensure facilities, equipment, and processes are ready for GMP production.
- Oversaw operational management of change controls, CAPAs, and non-conformances related to process validation.
- Developed and implemented validation standards for standard operating procedures, work instructions, and technical presentations.
- Provided expert guidance and insights during internal and external audits to ensure compliance and operational integrity.
Senior QA Validation Expert
Takeda
Neuchâtel, Switzerland
01.2019 - 01.2023
- Management of a team of 5 employees during CAPEX projects, Plant Shutdown time and routine activties
- Directed coordination of quality validation team activities, emphasizing delegation and team development.
- Oversaw seamless project implementation during plant shutdown, ensuring timely restart of production without compromising quality standards.
- QA Validation Lead for all project steps from concept phase to basic, detail design till routine handover with the use of ASTM approach.
- Manage risk assessment (QRM, PFMEA), process transfer protocol, validation plans, specifications, commissioning, qualification and validation activities on all validation area cleaning, sterilization, equipment, computerized system, HVAC, utilities and process including supporting studies.
- Change Control assessment, Non conformances troubleshooting, and QA partner in GMP audits
- Led QA validation for technology transfer of Facteur VIII recombinant protein (downstream purification) from Singapore to Neuchatel, overseeing all validation activities. ;
- QA Validation Lead for upstream and downstream capacity increase projects (addition of bioreactors, buffer and process tanks, nanofilter, chromatography skids, CIP stations) on two different product lines ;
QA Validation Expert
Baxter-Baxalta-Shire
Neuchâtel, Switzerland
01.2014 - 01.2019
- Support the definition of validation strategies related to process, cleaning, sterilization, equipment, computerized system, HVAC and utilities according to guidelines and internal procedures with the validation, engineering, manufacturing science groups and other stakeholders.
- QA lead on risk assessment (QRM, PFMEA), use of QbD approach and ASTM methodology.
- Approved URS, DQ, MVP, IOPQ, and PPQ protocols and reports following established procedures in different validation subjects and phases.
- Provide QA validation inputs to deviations, CAPAs, Change and investigations
- Act as SME in GMP audits & HA Inspections (preparation and presentation) FDA, Swissmedic and review of regulatory submission files
- Drive improvement, standardization and simplification of validation documents and Standard Operating Procedures
- Participated in installing a new manufacturing line for the tech transfer and scale-up project focused on the production of Von Willebrand recombinant protein (downstream purification).
- Contributed to projects that increased capacity through the addition of equipment and optimization of cleaning and processes for recombinant protein production.
Quality Assurance Specialist
Novartis Consumer Health
Nyon, Switzerland
01.2013 - 01.2014
- Gathered and analyzed comprehensive data sets to address identified critical product issues effectively.
- Executed detailed investigations of critical failures, focusing on documentation accuracy and procedural compliance to facilitate actionable recommendations.
- Engaged with diverse teams such as Quality Control, Regulatory Affairs, Analytical Science & Technology, Supply Chain, Safety, Finance, and Country Organization to drive strategic initiatives.
Organic Chemist Researcher
Merck Serono
Geneva, Switzerland
01.2010 - 01.2013
- Developed and optimized chemical libraries within timelines and budget constraints. while ensuring adherence to high-quality standards.
- Oversaw training programs for technicians to enhance skill sets and operational efficiency.
- Contributed to team meetings by regularly presenting project updates and supporting collaborations with external CMOs like Syngene India.
Education
Master of Science - Advanced Chemical Methodologies
University of Bologna
Italy01-2009
Skills
- Engaged and results oriented
- Negotiation and communication abilities
- Process Validation and Tech Transfers
- Risk Management, Quality by Design, ASTM
- Ability to drive change
- Interdepartmental leadership
- Manufacturing priority management
- Effective team interaction
- Critical thinking skills
Languages
Italian: mother tongue
French: full professional proficiency
English: full professional proficiency
Timeline
Associate Manager MSIT Validation
J&J Innovative Medicine
01.2024 - 01.2026
Senior QA Validation Expert
Takeda
01.2019 - 01.2023
QA Validation Expert
Baxter-Baxalta-Shire
01.2014 - 01.2019
Quality Assurance Specialist
Novartis Consumer Health
01.2013 - 01.2014
Organic Chemist Researcher
Merck Serono
01.2010 - 01.2013
Master of Science - Advanced Chemical Methodologies
University of Bologna