Isabel Vivacqua
@isabelvivacqua
Senior Project, quality and compliance leader in pharmaceutical and biotech.
BrazilWhat I'm looking for
I am a senior project and quality leader with over 15 years of international experience in GMP environments across pharmaceutical, biotech and medical device sectors. I have led high-impact regulatory, compliance and engineering projects across LATAM, Europe and Asia, and I combine technical rigor with pragmatic project delivery.
My background includes General Management for NNE in Latin America, Senior Project and Regulatory leadership for Novo Nordisk (Denmark) and expatriation roles in Denmark, France and China. I have led large teams, implemented compliance retrofit and greenfield projects, and delivered significant cost savings through regulatory and supply-chain optimizations.
I hold postgraduate degrees in Bioprocess Engineering and Statistical Quality Control, am a Six Sigma Black Belt and have proven strengths in stakeholder management, change management, and establishing governance for compliance projects. I seek to apply my cross-cultural leadership and technical expertise to drive regulatory compliance and successful project outcomes.
Experience
Work history, roles, and key accomplishments
NNLed expansions program as Aseptic Module Lead for Brazil and China, establishing project organization and global systems for change control and contamination control; China module delivered first among eight with high compliance and Brazil prepared using lessons learned.
NNManaged technology innovation projects and complex aseptic line retrofits to Annex 1 compliance across Brazil, France, USA and China, overseeing budgets, timelines and global implementation support.
NNLed strategic regulatory projects and RA process optimization across LATAM, centralizing regulatory file distribution and reorganizing supply chain network, delivering estimated USD 120M savings over two years.
General Manager
NNE Brazil
Jan 2011 - Dec 2014 (3 years 11 months)
Established and led NNE's Brazil subsidiary, growing operations from 2 to 49 employees, managing business administration, finance, contracts, quality and business development across LATAM.
Quality Project Manager
NNE China
Jan 2009 - Dec 2010 (1 year 11 months)
Supervised subcontractors during construction of a new aseptic plant in Tianjin, overseeing commissioning activities and ensuring compliance with quality and GMP requirements.
Quality Project Manager
NNE France
Jan 2007 - Dec 2009 (2 years 11 months)
Implemented a vaccine filling plant for GlaxoSmithKline, leading commissioning and validation activities on a €500M project to ensure regulatory and quality compliance.
Education
Degrees, certifications, and relevant coursework
FPFederal University of Paraná
Master of Science, Bioprocess Engineering
Post-graduation MSc in Bioprocess Engineering focused on bioprocess design and optimization.
FFFederal University of Juiz de Fora
Post-Graduation Specialization, Statistical Quality Control
Post-graduation specialization in Statistical Quality Control emphasizing statistical methods for quality assurance.
PPPontifical Catholic University of Paraná
Bachelor's Degree, Industrial Pharmacy and Biochemistry
Undergraduate degree covering Industrial Pharmacy and Biochemistry with training in pharmaceutical processes and biochemical analysis.
Tech stack
Software and tools used professionally
Availability
Location
BrazilAuthorized to work in
Job categories
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