Clinical Quality & Risk Manager
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Job Location:
Kuala Lumpur - Malaysia
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Clinical Quality & Risk Manager
Clinical/Medical/Regulatory
Kuala Lumpur Malaysia
Are you passionate about quality assurance and risk management in clinical trials Do you want to play a pivotal role in ensuring compliance participant safety and data integrity If so we are looking for a Clinical Quality & Risk Manager to join our team in the Clinical Medical and Regulatory department at Novo Nordisk. Read on and apply today!
Your new role
As the Clinical Quality & Risk Manager (CQRM) you will be responsible for overseeing quality assurance and risk management activities for clinical trials within the CDC ensuring compliance with regulations international guidelines and Novo Nordisk policies and processes. The CQRM role is pivotal in identifying potential risks implementing mitigation strategies and promoting continuous improvement in quality and risk management to safeguard participant safety and ensure data integrity. Other responsibilities include but are not limited to:
- Perform ongoing country-level quality risk assessments and develop actionable mitigation plans.
- Serve as the primary point of contact for CDC management and therapeutic area units on quality risk management and mitigation.
- Identify emerging risks using process analytics and digital tools turning data into actionable insights.
- Drive strategic quality planning to align clinical quality goals with organizational objectives regulatory standards and compliance requirements
- Provide data-driven monitoring of quality and compliance identify trends conduct root cause analyses and implement CAPAs to improve data quality.
- Provide quality oversight across clinical program lifecycles including audits inspections serious breach resolution and lead change management to secure stakeholder support.
- Coordinate SMEs for local training champion innovative centralized solutions and foster cross-functional collaboration.
Your new department
The Clinical Medical and Regulatory department is at the heart of Novo Nordisks clinical development activities. Based in a fast-paced and dynamic environment we are responsible for planning and executing clinical trials ensuring compliance with protocols SOPs GCP and regulatory requirements. Our team collaborates with clinical investigators medical educators CROs and research institutions to deliver high-quality clinical studies that make a difference in patients lives. With a focus on innovation process optimization and knowledge sharing we are committed to driving excellence in clinical development.
Your skills & qualifications
To be successful in this role we are looking for a candidate who possesses these qualifications:
- Bachelors degree in Life Sciences or related field minimum masters preferred.
- 5 years of relevant experience in clinical operations or quality role in the pharmaceutical industry or CRO.
- Demonstrated ability to ensure high-quality execution of clinical trial activities in compliance with ICH-GCP regulatory requirements and internal SOPs.
- Broad understanding of clinical R&D global regulations and regulatory submission/inspection management.
- Strong skills in GCP clinical development and quality management system.
Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this we approach our work with an unconventional spirit a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose mutual respect and a willingness to go beyond what we know delivers extraordinary results.
Deadline
30 December 2025. Applications are reviewed on an ongoing basis. The position may be closed before the deadline.
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
Novo Nordisk is not your typical healthcare a modern world of quick fixes we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science make healthcare more accessible and treat prevent and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real lasting change in health.
#LI-AMS1
Required Experience:
Manager
Key Skills
- Arm
- Risk Management
- Financial Services
- Cybersecurity
- COSO
- PCI
- Root cause Analysis
- COBIT
- NIST Standards
- SOX
- Information Security
- RMF
About Company
You will be part of the Gulf Cluster sales team based in Qatar. You will report to the Country Sales Manager. The local team consists of approx 10 employees, and has highly-engaged and experienced members that are looking for a new teammember.
