Job summary
This role leads the oversight and implementation of quality and compliance activities related to clinical trials, ensuring adherence to Good Clinical Practice (GCP) and regulatory standards. The position emphasizes inspection readiness, audit support, risk management, and effective response coordination across clinical teams in a regional context. It requires strong leadership skills, extensive knowledge of clinical research quality standards, and proficiency in managing complex inspection and audit processes.
Location and work setup
- Location
- Oslo
- Work setup
- On-site
Responsibilities
Lead and coordinate activities to maintain continuous inspection readiness and audit preparation across clinical trials within the region. Develop and implement training, best practices, and risk mitigation plans to ensure compliance with GCP and regulatory requirements. Organize and support mock inspections, manage logistics and stakeholder alignment, and prepare briefing materials. Support execution and follow-up of regulatory inspections and audits, including leading root cause analysis, corrective actions, and CAPA management. Foster a proactive culture of compliance and continuous improvement, collaborating with cross-functional teams including clinical operations, quality assurance, and country representatives.
Qualifications
Bachelor’s degree or higher in a scientific, medical, or healthcare-related field with over 10 years of experience in clinical research, clinical operations, or compliance. At least 4 years in a GCP compliance or equivalent quality role is preferred. Proven experience in CAPA development, inspection and audit management, and comprehensive knowledge of ICH-GCP and clinical trial regulatory standards. Strong leadership, communication, problem-solving, and organizational skills are essential. Fluency in English required. Ability to work independently in a multicultural environment and travel within the region as needed.