Clinical Quality & Risk Manager

TipTopJob.com Malaysia; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading global pharmaceutical company in Kuala Lumpur seeks a Clinical Quality & Risk Manager to oversee quality assurance and risk management for clinical trials. The role involves assessing risks, ensuring compliance with regulations, and providing oversight throughout clinical program lifecycles. Candidates should have at least 5 years of experience in clinical operations or a quality role and possess strong skills in GCP and quality management. This position offers an opportunity to drive excellence in clinical development while ensuring patient safety.

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

Responsibilities

• Oversee quality assurance and risk management activities for clinical trials.
• Perform ongoing country-level quality risk assessments.
• Drive strategic quality planning aligning with clinical quality goals.

Skills

Quality Assurance

Risk Management

Clinical Operations

GCP

Education

Bachelor's degree in Life Sciences or related field

Master’s degree

Job description

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:

Responsibilities

• 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

• 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.

Deadline

30 December 2025. Applications are reviewed on an ongoing basis. The position may be closed before the deadline.

Title Change Notice

>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.