Luciana Mansolelli
Chief Quality Officer at Minaris Advanced Therapies
- Role
- Chief Quality Officer at Minaris
- Location
- Morris Plains, NJ, US
- LinkedIn followers
- 500 followers
About Luciana Mansolelli
Seasoned leader of corporate functions, projects and programs, overseeing organizational reviews, communicating results to top management, and developing strategies based on organizational reviews• Extensive interactions with global health authorities and non-government bodies in drug development, manufacturing and commercial compliance and legal framework, across GxP disciplines and product lifecycles• Highly focused on simplification, elimination of redundancies and reduction of complexity• Technical development, tech transfer and validation for medical devices, biologics, cell and gene therapies and pharmaceuticals• Experience on enabling technologies and process engineering for complex manufacturing process development for multiple novel cell therapies including cell and gene therapy
Experience
Chief Quality Officer
Jun 2025 — Present
Education
FGV - Fundação Getulio Vargas
Master of Business Administration (MBA), Business, Management, Marketing, and Related Support Services
2021 — 2023
Universidade Estadual de Maringá
Pharmacy, Industrial Pharmacy
1990 — 1995
Skills
- Cgmp
- Regulatory Affairs
- Clinical Development
- Gamp
- Quality Management
- Pharmaceuticals
- Regulatory Requirements
- Ind
- Lims
- Six Sigma
- Gxp
- Formulation
- Quality Auditing
- Aseptic Processing
- Clinical Trials
- Drug Development
- Generic Programming
- Gcp
- Biopharmaceuticals
- Compliance
- Iso 13485
- Pharmaceutical Industry
- Sop
- Quality System
- Quality Systems
- V&V
- Fda
- Validation
- Capa
- Pharmacovigilance
- Gmp
- Trackwise
- Hplc
- Quality Assurance
- Pharmaceutics
- Cleaning Validation
- Cmc
- Process Validation
- Computer System Validation
- Biotechnology
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