Piacere, sono
Barbara Guerrieri
Rubiera,RE
Profilo professionale
Senior CMC Manager with over 20 years of experience in pharmaceutical, biotechnology, and medical device environments. Market-recognized profile combining deep drug product CMC expertise with late-stage development, tech transfer to CMOs, process and method validation, and regulatory submissions (EU & FDA). Proven ability to deliver complex CMC programs, and lead cross-functional and external partners through end-stage development milestones. Valued for pragmatic leadership, regulatory insight, and calm execution in complex environments.
Panoramica
30
anni di esperienza professionale
Esperienza lavorativa
Quince Therapeutics S.p.A.Medolla, MO
Senior CMC Manager
2021.05 - 2026.02 (4 education.years_Label & 9 education.months_Label)
Panoramica del lavoro
- Led end-stage drug product CMC activities, ensuring alignment with ICH, FDA, and EMA
- Successfully led drug product tech transfer to new CMOs, including on-site support for validation batch manufacturing
- Monitored and managed execution of the drug product testing and process validation on registration batches
- Served as primary CMC interface with CMOs and third-party vendors, ensuring accountability to timelines, data quality, and quality standards
- Owned preparation, revision of CTD Module 3, coordinating external partners and internal project teams
- Provided oversight of clinical batch stability programs, including data review, trend analysis, and verification
- Managing of MD documentations: DHR, DMR, DHF for substance-based medical devices
- Biotechnology (Combination Product)
JSB Solutions SrlParma, PR
Regulatory Affairs -Consultant
2021.01 - 2021.04 (3 education.months_Label)
Panoramica del lavoro
- Supported global Regulatory Affairs CMC activities for international pharmaceutical programs (RoW)
- Coordinated regulatory interactions with National Authorities
- Contributed to marketing authorization renewals and new registration applications
- Regulatory Affairs CMC - Life Science Consulting
Holostem Terapie Avanzate SrlModena, MO
QA and RA Manager
2009.11 - 2020.12 (11 education.years_Label & 1 education.month_Label)
Panoramica del lavoro
- Held progressively responsible roles in Quality Assurance and Regulatory Affairs CMC within an ATMP setting.
- Supported the entire product lifecycle from development to registration and post-approval changes for a Cell-Based ATMP approved in the EU.
- Led the preparation and maintenance of CMC documentation for EU submissions, including Modules 2 and 3, as well as variations.
- Managed interactions with the National Regulatory Authority during inspections and field actions.
- Oversaw Quality Assurance Management to ensure GMP compliance in manufacturing, control, and release activities.
- Served as a key cross-functional interface, supporting development, manufacturing, quality, and regulatory teams.
- Worked closely with internal departments to ensure timely and compliant submissions.
- Regulatory Affairs & Quality (CMC / GMP) ATMP - Biotechnology
Chiesi Farmaceutici S.p.A.Parma, PR
Quality Assurance Specialist
2002.09 - 2009.11 (7 education.years_Label & 2 education.months_Label)
Panoramica del lavoro
- Reviewed batch records for sterile and non-sterile products
- Managed process and analytical deviations and related CAPAs
- Handled quality complaints and product compliance activities
- Ensured compliance of specifications, manufacturing processes, and analytical methods
- Quality Assurance - Product Compliance & Release - Pharmaceutical Industry
Comef SrlCarpi, MO
Quality Manager
1995.10 - 2002.08 (6 education.years_Label & 10 education.months_Label)
Panoramica del lavoro
- Managed Quality Systems in compliance with ISO 9001 and ISO 13485
- Supported production and release of medical devices
- Quality Manager - Biomedical
Istruzione
Università di Parma
Master's Degree from Pharmaceutical Technologies and Regulatory Activities
01.2016
Università Modena e Reggio Emilia
University Degree from Chemistry
1995-01
Università Modena e Reggio Emilia
Qualified Chemist
1995-01
Competenze
- CMC, Drug Product
- Tech Transfer
- Product Development
- Budget Management
- Small Volume Sterile, Biologics e ATMP Products
- Pharmaceutical Quality System
- GMP & Regulatory Compliance
- CTD M3 Drafting
- ICH, EMA, FDA Regulations
- Effective Risk Management
Languages
Italian – Native
English – B2
Declaration
I authorize the processing of my personal data contained in this CV pursuant to EU Regulation 2016/679 (GDPR) for the purposes of recruitment and selection
Cronologia
Senior CMC Manager
Quince Therapeutics S.p.A.
2021.05 - 2026.02 (4 education.years_Label & 9 education.months_Label)
Regulatory Affairs -Consultant
JSB Solutions Srl
2021.01 - 2021.04 (3 education.months_Label)
QA and RA Manager
Holostem Terapie Avanzate Srl
2009.11 - 2020.12 (11 education.years_Label & 1 education.month_Label)
Quality Assurance Specialist
Chiesi Farmaceutici S.p.A.
2002.09 - 2009.11 (7 education.years_Label & 2 education.months_Label)
Quality Manager
Comef Srl
1995.10 - 2002.08 (6 education.years_Label & 10 education.months_Label)
Università di Parma
Master's Degree from Pharmaceutical Technologies and Regulatory Activities
Università Modena e Reggio Emilia
University Degree from Chemistry
Università Modena e Reggio Emilia
Qualified Chemist