Senior GCP Advisor – Clinical Quality & Compliance
Company: Novo Nordisk
Department: Novo Nordisk Quality – Global Business Services (GBS)
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Application Deadline: 1 March 2026
Industry: Clinical Quality & Regulatory Compliance
Job Overview
Novo Nordisk is hiring a Senior GCP Advisor to join its Quality GBS team in Bengaluru. This strategic leadership role focuses on ensuring global compliance with Good Clinical Practice (GCP) regulations across clinical development processes.
The Senior GCP Advisor will act as a quality partner to business stakeholders, manage content control and process governance for clinical trials, and support inspection readiness across global operations. This is a high-impact opportunity for experienced clinical quality professionals seeking global exposure within a regulated pharmaceutical environment.
Experience Required
10–12 years of experience in GCP compliance, clinical trial quality management, or related regulatory functions
Extensive experience in conducting and overseeing clinical trials
Strong exposure to Quality Management Systems (QMS), audits, and inspection support
Experience working in global cross-functional pharmaceutical environments
Educational Qualification
Degree in Medical, Biological, Pharmaceutical Sciences, or related discipline
Key Responsibilities
Manage content control and process governance for clinical trial operations on behalf of Process Quality Assurance (PQA).
Verify and approve Clinical Trial (CT) Standard Operating Procedures (SOPs) ensuring correct interpretation of GCP regulations.
Serve as a member of the CT SOP Council, advising line of business stakeholders on quality and compliance matters.
Maintain global CT SOPs in alignment with internal policies and external regulatory requirements.
Provide expert GCP advisory support during regulatory inspections and audits.
Collaborate with Process Managers and Process Quality Assurance Delegates (PQADs) to ensure continuous quality improvement.
Drive global consistency in clinical development processes through structured documentation and process oversight.
Act as a quality anchor for worldwide clinical development initiatives.
Influence strategic process optimization and support transformation projects within Development & Research.
Core Competencies & Skills
Deep knowledge of ICH-GCP guidelines and drug development lifecycle
Strong understanding of global regulatory frameworks impacting clinical trials
Extensive QMS and quality process expertise
Experience in audits, inspections, and compliance remediation
Strategic thinking with strong project management capabilities
Ability to influence stakeholders and lead quality-focused initiatives
Strong presentation, communication, and decision-making skills
Proficiency in IT systems and global documentation platforms
Ability to operate independently in a dynamic international environment
About the Department
R&D Quality is part of Novo Nordisk’s global Quality Organization, supporting drug and device development across the full value chain. The team partners with Regulatory Affairs, Global Safety, Clinical Reporting, and Clinical Data Sciences to ensure high-quality processes and regulatory compliance.
R&D Quality provides governance across deviations, SOP management, change controls, quality monitoring, system validations, and inspection readiness while supporting transformation initiatives in Development & Early Research.
Why Join Novo Nordisk?
With more than 100 years of innovation in chronic disease treatment, Novo Nordisk remains a global leader in diabetes, obesity, rare blood, and endocrine disorders. The organization combines regulatory excellence, patient-centricity, and scientific innovation to deliver life-changing therapies worldwide.
This role offers global exposure, strategic quality leadership, and the opportunity to influence clinical development standards within an internationally regulated pharmaceutical environment.
Important Information
Applications are reviewed on a rolling basis; early application is encouraged.
Novo Nordisk does not charge any fees during recruitment and does not extend unsolicited job offers.
The organization is committed to inclusive hiring and equal opportunity employment.
SEO Keywords:
Senior GCP Advisor Jobs India, Clinical Quality Jobs Bengaluru, Novo Nordisk Careers 2026, GCP Compliance Jobs Pharma, Quality Assurance Clinical Trials, CT SOP Governance Roles, Pharmaceutical QMS Jobs India, Global Clinical Quality Careers.
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