Renata Zimova
About Renata Zimova
Renata Zimova is the Global Head of Clinical QA at Novocure Inc. with extensive experience in clinical quality assurance and regulatory requirements.
Current Role at Novocure Inc.
Renata Zimova is the Global Head of Clinical QA at Novocure Inc., based in Portsmouth, New Hampshire, United States. In this role, she oversees clinical quality assurance operations, ensuring compliance with regulatory and GCP requirements. Renata is responsible for implementing QA strategies and managing health authority inspections for major regulatory bodies, including the FDA, EMA, and MHRA. Her leadership helps maintain high standards in clinical research and development at Novocure Inc.
Previous Experience at Icon Plc
Renata Zimova served at Icon Plc for nine years in Leopardstown, Dublin, Ireland. From 2011 to 2018, she was the Associate Director of Clinical Quality Assurance - Europe, and from 2008 to 2011, she was the Senior Manager of Quality Assurance - Europe. During her tenure at Icon Plc, she played a vital role in overseeing clinical quality assurance, ensuring adherence to regulatory guidelines across Europe. Her work contributed significantly to the company's regulatory and GCP compliance.
Experience at European Medicines Agency
From 2004 to 2008, Renata Zimova worked at the European Medicines Agency as a Gcp and Gmp Inspector in Amsterdam, North Holland, Netherlands. In this role, she conducted inspections and ensured compliance with good clinical practice (GCP) and good manufacturing practice (GMP) guidelines. Her involvement was crucial in maintaining the high standards required by the EMA.
Education at Charles University
Renata Zimova studied Medicine at Charles University, earning a degree in 1990 after six years of study. She continued her education at the same institution, achieving Doctorates, Doctor of Philosophy, from 2005 to 2011. Her rigorous academic background provided a strong foundation for her extensive career in clinical research, QA, and regulatory affairs.
Expertise in Clinical Research and Regulatory Affairs
With over 14 years of QA and regulatory experience in EMEA and international companies, Renata Zimova possesses deep expertise in clinical research and development, particularly in regulatory and GCP requirements. Her extensive knowledge spans GCP, GMP, and Pharmacovigilance, with a profound understanding of ICH GCP and EU GMP guidelines. Renata is known for her excellent leadership, teamwork, communication, and influencing skills, which she has demonstrated across various regions and cultures.