Clinical Quality & Risk Manager

Novo Nordisk Pharmaceuticals; Kuala Lumpur; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical company in Kuala Lumpur is seeking a Clinical Quality & Risk Manager to oversee quality assurance and risk management for clinical trials. Responsibilities include conducting risk assessments, implementing mitigation plans, and ensuring compliance with regulations. Candidates should have at least 5 years of experience and a relevant bachelor's degree. This role is pivotal in promoting data integrity and participant safety within clinical development activities.

Qualifications

• 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.
• Broad understanding of clinical R&D and global regulations.

Responsibilities

• Oversee quality assurance and risk management activities for clinical trials.
• Identify potential risks and implement mitigation strategies.
• Drive strategic quality planning to align clinical quality goals.

Skills

Quality Assurance

Risk Management

Clinical Development

Data Analysis

Education

Bachelor’s degree in Life Sciences

Master’s degree in related field

Job description

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 Nordisk’s 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:

• Bachelor’s degree in Life Sciences or related field minimum, master’s 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.