Director of Quality and Compliance Oversight
vor 1 Monat
Job Overview
The Associate Director, Quality Assurance and Compliance (QAC) role at Veristat Europe is a critical position that requires expertise in quality management, compliance, and regulatory affairs.
About Us
Veristat is a global expert in clinical development with over 27 years of experience supporting rare disease clinical trials. Our team has supported over 760+ trials, including 160+ marketing applications, with 8 regulatory approvals in 2022.
Our Offer
This full-time role offers a competitive salary range of 100-165K CHF, plus applicable bonus, depending on location. Benefits may include remote working, flexible time off, paid holidays, medical insurance, tuition reimbursement, and retirement plans.
Key Responsibilities
- Lead European clinical quality assurance activities, ensuring compliance with Good Clinical Practices (GCP), Electronic Records/Signatures, and the Quality Management System.
- Develop and implement quality policies, procedures, and infrastructure to support Veristat's global operations.
- Serve as liaison for compliance-related activities, providing oversight and guidance to staff.
- Maintain up-to-date knowledge of global clinical research regulations, including ICH E6 GCP and 21CFR-Part11.
Requirements
- Bachelor's degree in a science-related field; advanced degree preferred.
- At least 8 years of GCP experience in an FDA, MHRA, EMA, or other regulated environment; minimum 5 years in the sponsor and/or Full Service CRO industry.
- Demonstrated leadership skills, ability to lead by example, and technical supervisory experience.
- Experience with Quality Management System (QMS) design, requirements, and implementation.
- Familiarity with electronic systems related to GxP regulations.
We Celebrate Diversity
Veristat is an equal opportunity employer committed to creating an inclusive environment for all employees. We welcome applicants from diverse backgrounds and perspectives.
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