Sara Taglialatela

Global Quality Systems & Compliance Sr. Director at Kedrion Biopharma

Sara Taglialatela, Pharm.D. has a diverse work experience in the pharmaceutical industry. Sara started their career as a Regulatory Affairs Assistant at Segix Italia Srl in 2001, followed by a role as a Regulatory Affairs Specialist at Pfizer from 2001 to 2004. From 2004 to 2008, they worked at Pierrel Spa as a Regulatory Affairs and GMP Compliance Advisor, where they managed projects, prepared regulatory dossiers, and conducted inspections.

In 2009, Sara joined Kedrion Biopharma as a GMP Compliance Manager, responsible for quality system management and ensuring compliance with regulations. Sara then became a Quality Compliance Manager from 2012 to 2018, overseeing quality and regulatory compliance at Kedrion's manufacturing plant in Naples.

Sara's next role was as a Quality Assurance Manager and Qualified Person at Kedrion Biopharma, where they led a team of 23 people and managed the GMP Quality System. Sara also handled regulatory affairs, prepared CMC files, and conducted audits and inspections.

Currently, Sara holds the position of Global Quality Operations Manager and QP at Kedrion Biopharma. Their responsibilities include designing and monitoring quality processes, supporting plants in remediation and inspection readiness activities, and managing a team of professionals. Sara is also the Qualified Person for the Kedrion plant in Naples, Italy.

Sara Taglialatela, Pharm.D. holds a Laurea in CTF (Chimica e tecnologia farmaceutica) from Università degli Studi di Napoli Federico II, which they obtained from 1995 to 2000. Prior to that, they received a Diploma di Maturità Classica from Liceo Classico, with no specific field of study mentioned. In addition, they have certifications including Qualified Person from AIFA Agenzia Italiana del farmaco, Role Model from Valore D, and The European Qualified Person Association from ECA Foundation & ECA Academy.

Links

Previous companies

Pierrel logo
Pfizer logo

Timeline

  • Global Quality Systems & Compliance Sr. Director

    April, 2021 - present

  • Global Quality Operations Manager And QP

    October, 2020

  • Quality Assurance Manager And Qualified Person

    December, 2018

  • Quality Compliance Manager

    October, 2012

  • GMP Compliance Manager

    February, 2009

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