Job Description

Band

Level 5#LI-Onsite
Location: Selangor, Malaysia

This role is based in Selangor, Malaysia. Please only apply if this location is accessible for you.

As Country Quality Head you will lead the Quality function for the Malaysia and Brunei Country Organization, ensuring all quality-relevant processes within the scope of Malaysia and Brunei are compliant with Novartis standards, Health Authority requirements, and applicable GxP regulations.

In this role you will ensure quality governance and proactive oversight to prevent regulatory or quality non-compliance that could affect product availability, approvals, financial performance, or company reputation. Drive company-wide standardization, operational excellence, innovation, and a strong quality culture across Malaysia and Brunei.

This is a pivotal leadership role responsible for safeguarding patient trust, enabling business continuity, and strengthening Quality excellence across Malaysia and Brunei. We look forward your application!

This is a pivotal leadership role responsible for safeguarding patient trust, enabling business continuity, and strengthening Quality excellence across Malaysia and Brunei. We look forward your application!

Deadline for applications: 30th of July 2026.

Major Accountabilities:

• Lead and strengthen the cross-divisional Quality Culture across Malaysia and Brunei, promoting high standards of data integrity, compliance awareness, accountability, and collaboration with business partners.
• Provide effective Quality governance and oversight across commercial, clinical, and pharmacovigilance activities, ensuring implementation of the Country Quality Plan and alignment with business priorities.
• Ensure robust management of key quality processes, including commercial batch release, change control, complaints, risk assessments, CAPA, deviations, quality agreements, and GxP-related activities.
• Serve as the key Quality contact for Health Authority interactions related to field alerts, drug shortage reporting, inspections, commitments, and quality-related regulatory matters.
• Monitor, review, and report Key Quality Indicators and quality risks through Country Quality Committees and Executive Committees, ensuring timely escalation and resolution of critical issues.
• Lead the implementation of applicable Quality Standards, SOPs, and Quality Manual requirements, ensuring alignment with local Health Authority regulations and Novartis global requirements.
• Ensure inspection readiness and successful execution of Health Authority inspections, internal audits, and external audits, including timely closure of observations and commitments.
• Build and develop a high-performing Quality team by attracting, coaching, mentoring, and retaining talent while fostering an inclusive culture and supporting succession planning.

Obligatory Requirements:

• Bachelor’s degree or equivalent four-year university qualification in a scientific or technical field such as Pharmacy, Chemistry, Life Sciences, or a related discipline; advanced degree preferred.
• Minimum of 12 years of experience in the pharmaceutical industry, with strong exposure to Quality, Commercial Quality, Quality Operations, Manufacturing, Development, or related GxP areas.
• Expert knowledge of GxP regulations and quality expectations from major Health Authorities, with the ability to apply requirements in a country and regional operating environment.
• Proven experience developing, implementing, and improving Quality Management Systems, including compliance oversight, auditing, CAPA, deviation management, risk management, and inspection readiness.
• Experience interacting with Health Authorities, supporting regulatory inspections, managing commitments, and handling quality-related regulatory matters.
• Strong understanding of regulatory submissions, product lifecycle management, portfolio management, commercial batch release, and supply continuity considerations.
• Demonstrated leadership experience in a complex matrix organization, with the ability to influence senior stakeholders, lead change, manage resistance, and drive cross-functional alignment.
• Excellent communication, negotiation, coaching, talent development, and stakeholder management skills
• English and Malay fluent, written and spoken; additional languages are an advantage.

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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Skills Desired