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Senior Director, Quality Assurance and Compliance at SFL Regulatory Affairs and Scientific Communication, GmbH. Location Information: UK, Germany, France, Ireland, Switzerland, Spain. This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. . . Role Description. The Senior Director, Quality Assurance (QA) and Compliance is responsible for ensuring compliance with all relevant guidelines and regulations, overseeing quality management and training, ensuring that Veristat as a company has appropriate corporate policies, procedures, and infrastructure, and that staff are qualified to perform regulated tasks, and adhere to Standard Operating Procedures (SOPs).. The Senior Director, QA & Compliance is ultimately responsible for providing strategic direction and leadership to the department to best achieve departmental and company goals. In conjunction, s/he also participates as a member of the Senior Leadership Team.. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.. 105+ approved therapies for marketing applications prepared by Veristat. 480+ oncology projects in the past 5 years. 350+ rare disease projects delivered in the past 5 years. Flexible, inclusive culture — 70% remote workforce, 66% women-led teams. Qualifications. Bachelor’s Degree in a science or related field required; Master’s Degree preferred. 10 or more years of relevant industry experience in Quality Assurance/Compliance required, with at least 8 years of direct management experience. Expert knowledge of International Conference on Harmonisation (ICH), Food and Drug Administration (FDA), and other regulatory body guidelines. Experience managing audits and/or FDA/European Union (EU) inspections. Experience in participating in regulatory body inspections and inspection readiness activities. Working experience in quality system programs of training, CAPA and document control. Excellent written and oral communication skills. Strong leadership and management skills. Demonstrated ability to work in a cross-functional team environment. Demonstrated problem-solving ability and aptitude to process complex quality issues. Expert in relevant regulations and guidelines including 21CFR-Part11, GCP, and QSIT. Requirements. Expert knowledge of ICH, FDA, and other regulatory body guidelines. Experience managing audits and/or FDA/EU inspections. Experience in regulatory body inspections and inspection readiness activities. Working experience in quality system programs of training, CAPA, and document control. Excellent communication skills. Strong leadership and management skills. Ability to work in a cross-functional team environment. Problem-solving ability for complex quality issues. Expert in regulations including 21CFR-Part11, GCP, and QSIT. Benefits. Remote working. Flexible time off. Paid holidays. Medical insurance. Tuition reimbursement. Retirement plans