Open to opportunities

Flavio Santoro

@flaviosantoro

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Experienced Quality Control Director with a focus on operational excellence.

Italy

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What I'm looking for

I am seeking a role that values quality and innovation, with opportunities for growth.

I am Flavio Santoro, a dedicated Quality Control Director with extensive experience in the pharmaceutical industry. Currently, I lead a team of over 45 professionals at Dompè Farmaceutici, where I manage the department's budget and oversee project management initiatives, including Quality CAPEX. My expertise in analytical methods and quality systems has been instrumental in ensuring compliance with regulatory standards.

Throughout my career, I have held various leadership roles, including Quality Control Manager and Deputy Qualified Person at Alfasigma. My commitment to operational excellence is reflected in my successful implementation of Lean Manufacturing and 6 Sigma tools. I thrive in collaborative environments, empowering teams to achieve their best while maintaining a strong focus on quality and compliance.

Experience

Work history, roles, and key accomplishments

Current

Quality Control Director

Current

Dompè Farmaceutici S.p.A.

Jan 2023 - Present (2 years 6 months)

Led a Quality Control Team of over 45 members, reporting directly to the Chief Industrial Officer. Managed the department's OPEX budget and oversaw Quality CAPEX projects.

Quality Control Budget Management Project Management Quality Management SOPs OPEX Data Integrity Change Control

Quality Control Manager & Deputy Qualified Person

Alfasigma – Biosint S.p.A.

Sep 2021 - Present (3 years 10 months)

Managed a Quality Control Team of 10+ members, reporting to the Quality Director. Oversaw analytical methods, budget, and quality system topics including deviations and change control.

Quality Control Budget Management Project Management SOPs Change Control

Quality Control Lead

Takeda – Baxter Manufacturing S.p.A.

Jun 2017 - Present (8 years 1 month)

Led a Quality Control Team of 10+ members, reporting to the Head of Quality. Managed department budget, quality CAPEX, and ensured compliance with regulatory standards.

Quality Control Budget Management Project Management SOPs Quality Management Change Control

Chemical Lab Specialist/Supervisor

Shire – Baxter Manufacturing S.p.A.

May 2012 - Present (13 years 2 months)

Supervised an 8-member Chemical Lab Team and approved analytical results. Managed laboratory investigations, non-conformities, and change control systems.

Quality Control SOPs Change Control Laboratory Investigations Analytical Results Approval

Chemical Lab Technician/Quality Coordinator

Baxter Manufacturing S.p.A.

Sep 2009 - Present (15 years 10 months)

Authored method validation and qualification protocols, as well as Standard Operating Procedures. Executed analytical assays using various laboratory instruments.

Technical Writing SOPs

Education

Degrees, certifications, and relevant coursework

Sapienza – Università di Roma

Master degree, Pharmaceutical Chemistry/Industrial Pharmacy

Grade: 110/110

Completed a Master's degree in Pharmaceutical Chemistry/Industrial Pharmacy, achieving a perfect score of 110/110. This program provided a comprehensive understanding of pharmaceutical processes and industrial applications.

L“

Liceo Scientifico “Nomentano”

Diploma, Scientific Studies

Obtained a Scientific High School Diploma, focusing on scientific subjects. This foundational education provided a strong base in various scientific disciplines.

National Research Council of Italy – Chemical Methodology Department

Research Activity, Nuclear Magnetic Resonance (NMR) in Food Chemistry

Conducted research activity in the field of Nuclear Magnetic Resonance (NMR) and its application in food chemistry. This experience provided hands-on research skills and specialized knowledge in analytical methodologies.