Senior Gcp Advisor

14+ years

Not Disclosed

Bangalore India

10 Feb. 12, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior GCP Advisor

Location: Bangalore, India
Department: R&D Quality GBS
Job Category: Quality
Application Deadline: 17th February 2025

ABOUT NOVO NORDISK

Novo Nordisk is a global healthcare leader with over 100 years of innovation in tackling chronic diseases such as Diabetes, Obesity, Haemophilia, and Growth Disorders. Our commitment to improving patient lives impacts over 40 million people daily, making us one of the top 20 most valuable companies by market capitalization.

At Novo Nordisk, we foster a culture of inclusion, innovation, and collaboration, striving to be the best company for the world by empowering our employees and creating life-changing solutions.

POSITION OVERVIEW

We are seeking a Senior GCP Advisor to ensure Good Clinical Practice (GCP) compliance, manage clinical supplier assessments, and support global quality initiatives. This role involves cross-functional collaboration, regulatory compliance, and process optimization within a fast-paced, innovation-driven environment.

KEY RESPONSIBILITIES

Compliance & Risk Management

Serve as a subject matter expert (SME) in GCP compliance and clinical supplier assessments.
Evaluate compliance with ICH/GCP guidelines and work with Clinical Outsourcing Management to mitigate identified risks.
Review and approve action plans for global GCP audit findings and provide insights for continuous improvement.
Support GCP audits and inspections conducted by Health Authorities worldwide.

Quality Oversight & Process Improvement

Conduct cross-functional data trend analysis to identify quality risks and share findings with global stakeholders.
Provide GCP training and drive quality and compliance awareness across the organization.
Participate in process improvement initiatives to enhance efficiency and regulatory alignment.
Contribute to GCP working groups and transformational projects in Research & Development (R&D).

Stakeholder Collaboration & Knowledge Sharing

Ensure quality oversight by working closely with internal and external stakeholders.
Promote a culture of knowledge-sharing and continuous learning within the organization.
Assist in Clinical Vendor Assessments to ensure adherence to quality and regulatory requirements.

QUALIFICATIONS & EXPERIENCE

Education:
- Degree in Medical, Biological, or Pharmaceutical Sciences (or related field).
Experience:
- 14+ years of experience in Good Clinical Practice (GCP) and clinical trial requirements.
- In-depth understanding of GCP guidelines, regulatory requirements, and Quality Management Systems (QMS).
- Experience in clinical vendor assessments and quality processes.
- Prior global, cross-functional experience preferred.
Skills:
- Strong risk-based mindset and ability to apply analytical thinking to quality aspects.
- Excellent communication and stakeholder management skills.
- Ability to work flexibly, collaboratively, and strategically with a focus on digital innovation.

ABOUT THE DEPARTMENT

R&D Quality GBS plays a crucial role in ensuring high-quality processes throughout the drug and device development lifecycle.

We support quality management across:
✔ Regulatory Affairs
✔ Global Safety
✔ Clinical Reporting GBS
✔ Clinical Data Sciences GBS

Our focus is to drive quality excellence and support transformational projects in Research & Early Development to deliver innovative healthcare solutions.

WORKING AT NOVO NORDISK

Novo Nordisk is committed to:
✅ Diversity & Inclusion – Celebrating different perspectives, backgrounds, and cultures.
✅ Career Growth – Providing opportunities for professional development and advancement.
✅ Work-Life Balance – Offering flexible working arrangements based on business needs.

We believe in creating impact beyond business—making a difference for patients, employees, and society.

HOW TO APPLY

If you are a match for this role, submit your CV and motivational letter online by clicking "Apply Now" and following the instructions.

IMPORTANT NOTICE

⚠ Beware of fraudulent job offers. Novo Nordisk does NOT:

Send unsolicited employment offers.
Charge candidates any recruitment fees.
Request payments for training or equipment.

For verification, please refer to official Novo Nordisk channels.

🚀 Join Novo Nordisk and be part of a life-changing journey in healthcare innovation!

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