Senior GCP Advisor – Quality (Clinical Development)
Location: Bangalore, Karnataka, India
Department: Quality – Novo Nordisk GBS
Company: Novo Nordisk
Application Deadline: 1 March 2026
Job Overview
Novo Nordisk is seeking an experienced Senior GCP Advisor to join its Quality GBS team in Bangalore. This strategic leadership role supports global clinical development by ensuring compliance with Good Clinical Practice (GCP) regulations, Quality Management Systems (QMS), and global clinical trial governance standards.
The position is ideal for senior clinical quality professionals with deep expertise in GCP compliance, SOP governance, inspection readiness, and cross-functional quality leadership within pharmaceutical drug development.
Key Responsibilities
Serve as GCP Advisor within Process Quality Assurance (PQA) for global clinical trials.
Manage content control and process management activities to ensure full compliance with global GCP regulations.
Verify, review, and approve Clinical Trial (CT) Standard Operating Procedures (SOPs) and ensure correct interpretation of GCP guidelines.
Act as a core member of the CT SOP Council, advising line-of-business stakeholders on quality risks and compliance matters.
Maintain global CT SOP framework and ensure adherence to internal policies and external regulatory requirements.
Collaborate closely with Process Managers and Process Quality Assurance Delegates (PQADs).
Provide expert support during global GCP inspections and regulatory audits.
Ensure consistency and compliance across global clinical development processes through structured documentation and governance.
Drive continuous improvement initiatives to optimize quality systems and process efficiency.
Act as a quality anchor across worldwide clinical development operations.
Required Experience and Qualifications
Degree in Medical, Biological, Pharmaceutical Sciences, or a related discipline.
Minimum 10–12 years of experience in GCP compliance, clinical trial quality assurance, and QMS within pharmaceutical drug development.
Extensive hands-on experience in conducting and overseeing clinical trials.
Strong knowledge of global GCP regulations and regulatory frameworks impacting clinical research.
Proven experience in audit management and inspection readiness support.
In-depth understanding of drug development lifecycle and life cycle management processes.
Experience working in global, cross-functional project environments.
Strong leadership, stakeholder management, and influencing skills.
Demonstrated ability to interpret complex quality regulations and translate them into operational processes.
Project management capabilities and experience coordinating global quality processes.
Advanced communication, presentation, and IT proficiency.
About the R&D Quality Function
R&D Quality is part of the global Quality Organisation at Novo Nordisk and plays a critical role in safeguarding quality across the drug and device development value chain. The function supports Regulatory Affairs, Global Safety, Clinical Reporting, and Clinical Data Sciences by providing governance over:
Quality Management Systems (QMS)
SOP lifecycle management
Deviation and change control processes
Quality monitoring and process reviews
System validations
Compliance oversight in global transformation initiatives
The team operates in a highly collaborative, international environment focused on delivering high-quality, compliant, and patient-centric development programs.
Why Join Novo Nordisk?
With more than a century of scientific innovation, Novo Nordisk continues to lead in chronic disease treatment and global healthcare transformation. The organization offers a dynamic, purpose-driven environment where quality, compliance, and innovation intersect to support millions of patients worldwide.
Professionals joining this role will have the opportunity to shape global clinical quality frameworks and influence strategic process excellence initiatives at scale.
Application Process
Candidates are encouraged to apply online by submitting their updated CV before 1 March 2026. Applications will be reviewed on a rolling basis.
Novo Nordisk maintains a transparent and ethical recruitment process and does not request any payment or fees during hiring.
Equal Opportunity Statement
Novo Nordisk is committed to an inclusive recruitment process and equal opportunity for all applicants.
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