Benefits

Education

Bachelor's degree

Full Job Description

Role Overview As a Compliance Manager within the Audits and Inspections team, you will be responsible for managing all aspects of GxP audits and Regulatory Authority inspections for the company, investigator sites, and clients. The Compliance Manager leads and/or reviews complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. What You Will Do Provide consultation to project teams and clients on GxP audit and inspection readiness, preparation, management, and follow-up activities. Support client audits and GxP regulatory authority inspections of the company, investigator sites, and sponsors. Why It Might Be a Fit Contribute to lessons learned discussions and participate in company-wide improvement initiatives. Develop and effectively share guidance and reference information, repositories, and communication channels. Requirements Bachelor's degree or equivalent and relevant formal academic / vocational qualification 5+ years of quality assurance experience Extensive knowledge of GxP, with GCP required Proven expertise and experience in quality management systems and regulatory frameworks Proven experience in root cause analysis Strong problem solving, critical thinking, risk assessment and impact analysis abilities Exceptional communication (verbal and written) and presentation skills Advanced proficiency in Microsoft Office Suite and compliance-related software Benefits Global team that values passion, innovation, and a commitment to scientific excellence Collaboration and development are part of the everyday experience Contributions truly make a difference

Skills and Technologies