Sr GCP Advisor

Roles & Responsibilities:
• Manage Content Control and Process Management activities for Clinical Trials
• Ensure compliance with GCP regulations on behalf of Process Quality Assurance (PQA)
• Verify and approve Clinical Trial SOPs and ensure correct interpretation of GCP guidelines
• Serve as GCP Advisor and member of the Clinical Trial (CT) SOP Council
• Provide quality guidance to Line of Business (LOB) stakeholders
• Maintain and ensure global consistency of CT SOPs in line with internal and external requirements
• Collaborate with Process Managers and Process Quality Assurance Delegates (PQAD)
• Provide inspection readiness support and assist during GCP audits and regulatory inspections
• Act as quality anchor for global clinical development processes
• Support continuous quality improvement initiatives and QMS optimization
• Facilitate global cross-functional collaboration and process harmonization
• Present and manage complex quality issues in an international environment

Qualification:
• Degree in Medical / Biological / Pharmaceutical Sciences or related field

Experience:
• 10–12 years of experience in GCP and clinical trial quality
• Extensive experience in clinical trial conduct and drug development lifecycle
• Experience in Quality Management Systems (QMS)
• Experience in audit and inspection support
• Global cross-functional exposure preferred

Skills:
• Strong knowledge of GCP regulations and drug development processes
• Expertise in SOP governance and quality systems management
• Strategic thinking with process optimization mindset
• Strong leadership and stakeholder influencing skills
• Project management and global coordination abilities
• Ability to work independently and make confident decisions
• Excellent communication, presentation, and IT skills
• Adaptability in dynamic, international environments

About the Organization:
Novo Nordisk is a global healthcare company focused on defeating diabetes and other serious chronic diseases. Through its R&D Quality organization, Novo Nordisk ensures high standards of quality and compliance across the drug development lifecycle, supporting innovative treatments that improve patients’ lives worldwide.