Quality Assurance Specialist

Novartis; Selangor; On-site; MYR 60,000 - 110,000; Full time

Job summary

Novartis in Selangor, Malaysia is seeking a Quality Assurance Specialist to strengthen quality systems and regulatory compliance for pharmaceutical products and medical devices. You will lead inspections, oversee product release, and partner with cross-functional teams to ensure data integrity and continuous improvement.

The role focuses on maintaining quality standards, coordinating with regulators and suppliers, and promoting a culture of quality across the organization.

Qualifications

• Degree in life sciences or related field.
• Experience in quality assurance or quality control within pharma/healthcare.
• Knowledge of GMP and GDP requirements.
• Understanding of local regulations and medical-device requirements.
• Fluency in English and local language.
• Strong communication and stakeholder-management skills.

Responsibilities

• Maintain quality systems and GMP/GDP compliance.
• Oversee product release against specifications and regulatory requirements.
• Monitor quality indicators and coordinate risk-mitigation actions.
• Manage inspections, complaints, deviations, recalls, and CAPA.
• Provide quality oversight for third-party manufacturing and distribution.
• Support medical-device compliance, safety actions, and regulatory reporting.
• Promote data-integrity and a culture of responsible data management.
• Collaborate with supply chain, regulatory affairs, and external partners.

Skills

Quality assurance

GxP knowledge

Regulatory compliance

Communication

Stakeholder management

Education

Bachelor's degree in life sciences

Tools

LIMS

Regulatory databases

Job description

Band

Level 3

Job Description Summary

#LI-Onsite

Location

Selangor, Malaysia

Relocation Support

This role is based in Selangor, Malaysia. Novartis is unable to offer relocation support: please only apply if accessible.

Make quality count where it matters most: protecting patients and ensuring trusted medicines reach them safely. As a Quality Assurance Specialist, you will strengthen quality and compliance across pharmaceutical products and medical devices, collaborating with internal teams, external partners, and regulatory authorities. You will help maintain robust quality systems, support inspection readiness, oversee product-release activities, and promote a strong culture of data integrity and continuous improvement across the organization.

Job Description

Deadline for applications: 28th October 2026.

Major Accountabilities

• Maintain quality systems and procedures supporting Good Manufacturing Practice and Good Distribution Practice compliance.
• Oversee product release against registered specifications and applicable regulatory requirements.
• Monitor key quality indicators, identify gaps, and coordinate timely risk-mitigation actions.
• Manage inspections, complaints, deviations, recalls, product tampering, and corrective and preventive actions.
• Provide quality oversight for third-party manufacturing, packaging, labelling, storage, and distribution activities.
• Support medical-device compliance, licensing, safety actions, complaint handling, and regulatory reporting.
• Promote data-integrity awareness and coordinate plans that strengthen a culture of responsible data management.
• Partner with supply chain, regulatory affairs, external suppliers, and regulatory authorities on quality matters.

Essential Requirements

• Degree in life sciences or a related field.
• Experience in quality assurance or quality control within the pharmaceutical or healthcare industry.
• Knowledge of Good Manufacturing Practice and Good Distribution Practice requirements.
• Understanding of local pharmaceutical regulations, quality standards, and applicable medical-device requirements.
• Fluency in written and spoken English and the local language.
• Strong communication, collaboration, and stakeholder-management skills across cross-functional and external partnerships.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?