Associate Director Quality Assurance and Compliance

Associate Director Quality Assurance and ComplianceThe Associate Director, Quality Assurance and Compliance (QAC) – Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures compliance with Good Clinical Practices (GCP), Electronic Records/Signatures, and the Quality Management System within Veristat Europe.This role supports the global head of QAC and serves as liaison for compliance related activities to all Veristat personnel, providing oversight from a corporate level. Responsibilities include but are not limited to, quality management and training, ensuring that Veristat as a company has appropriate policies, procedures, and infrastructure, and that QAC staff are qualified to perform related tasks.What we doFor more than 27 years, Veristat has built a reputation as global experts in clinical development.760+ Rare Disease Clinical Trials supported160+ Marketing Applications supportedIn 2022 we supported 8 marketing application that received regulatory approvalLearn more about our core values here!What we offerThe estimated hiring range for this role is 100-165K CHF plus applicable bonus. This hiring range is specific to Switzerland and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.Benefits vary by location and may include:Remote workingFlexible time offPaid holidaysMedical insuranceTuition reimbursementRetirement plansWhat we look forBachelor’s degree required; science-related degree preferred. 8+ years of GCP experience in an FDA, MHRA, EMA, and/or other competent authority regulated environment required, to include a minimum 5 years in the sponsor and/or Full Service CRO industry preferred, and at least 5 years of supervisory experience required. Equivalent combinations of experience acceptable.Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff required.Solid understanding of global clinical research regulations, including but not limited to ICH E6 Good Clinical Practice, and 21CFR-Part11 required.Knowledgeable in Quality Management System (QMS) design and requirements, including document control, CAPA, and training required.Experience with implementation and management of GxP related electronic systems required. #J-18808-Ljbffr