Country Quality Head

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