Job summary
This senior leadership role focuses on managing and ensuring compliance with Good Clinical Practice and regulatory requirements across clinical trials within a defined region. The position drives inspection readiness, audit preparation and response activities, and collaborates with internal and external stakeholders to uphold high standards and manage complex inspection situations effectively.
Location and work setup
- Location
- Oslo
- Work setup
- On-site
Responsibilities
Lead and oversee regional and global clinical inspections and audits, ensuring high-quality handling and consistent compliance with regulatory standards. Drive inspection readiness programs including training, mock inspections, risk assessments, and documentation maintenance. Coordinate cross-functional teams for audit preparation, execution, and follow-up activities. Serve as the escalation point during inspections, supporting high-level engagement with regulatory authorities. Manage CAPA processes for identified findings, ensuring effective remediation and continuous improvement. Maintain alignment with global compliance frameworks and promote a proactive culture of inspection readiness within the clinical operations environment.
Qualifications
Bachelor's degree or higher in a scientific, medical, or healthcare discipline. Extensive experience in clinical research, clinical operations, and GCP compliance roles, including multiple years leading quality or compliance activities. Strong knowledge of ICH-GCP, regulatory guidelines, clinical trial processes, and quality management systems. Experience with CAPA development, audit and inspection management, and risk-based inspection preparation. Proven leadership and stakeholder management skills in complex, global contexts. Excellent communication, problem-solving, and organizational abilities. Fluency in English is required. Ability to travel internationally as needed.