Quality Control Manager APAC; Kelapa Gading

Quality Manager APAC will lead the quality function for the APAC business and own quality governance across the region’s external manufacturing and supplier network. As the APAC organization operates without internal manufacturing sites, the role is primarily focused on ensuring that external manufacturing partners and critical suppliers are qualified, compliant, capable and consistently able to deliver products and materials to the required quality standards.

The role will also lead the Quality workstream for technology transfers from manufacturing sites in other hubs into APAC external manufacturing partners, ensuring robust transfer readiness, appropriate validation and documentation, and successful transfer execution.

The position will establish and maintain the APAC quality framework, provide risk-based oversight of external partners, lead audits and remediation, govern quality incidents and CAPA, and ensure ongoing compliance with applicable regulatory, GMP, certification and company requirements. The role will work closely with Supply Chain, Procurement, R&D, Regulatory Affairs, Global Quality, other manufacturing hubs, external manufacturers and suppliers.

• APAC Quality Leadership & Governance
• Lead the APAC Quality function and establish a clear quality governance framework for the external manufacturing and supplier network.
• Develop, implement and maintain APAC quality policies, standards, procedures and governance mechanisms in alignment with global quality requirements.
• Define quality expectations and performance standards for external manufacturers, suppliers and other critical third parties.
• Provide quality leadership and coaching to the APAC team and relevant cross-functional stakeholders.
• Establish clear escalation mechanisms for critical quality, compliance and product risks and ensure timely management visibility.
• Provide regular quality performance updates, risks, trends and priorities to senior management.
• External Manufacturing Quality
• Own quality assurance and governance of APAC external manufacturing partners, from qualification and onboarding through ongoing performance management.
• Lead risk-based qualification, assessment and approval of external manufacturing sites, including quality due diligence and audit requirements.
• Establish and maintain appropriate Quality Agreements with external manufacturing partners.
• Conduct and/or lead risk-based audits of external manufacturing sites and ensure effective closure of audit findings and non-conformities.
• Monitor external manufacturer quality performance through defined KPIs, quality reviews, trend analysis and periodic performance assessments.
• Drive robust CAPA and continuous improvement plans with external manufacturers and verify effectiveness of corrective actions.
• Escalate significant quality or compliance concerns and recommend appropriate remediation, restrictions or disqualification where requirements are not met.
• Supplier Quality Management
• Own the quality governance framework for critical raw material, packaging and other strategic suppliers across APAC.
• Support supplier qualification, risk assessment, approval and ongoing quality performance monitoring.
• Establish appropriate supplier audit and quality surveillance programs based on risk and criticality.
• Monitor supplier quality trends, non-conformities, complaints, deviations and CAPA, ensuring timely and effective resolution.
• Partner with Procurement and Supply Chain to address supplier performance risks while maintaining quality and compliance requirements.
• Drive supplier quality improvement and strengthen the resilience and reliability of the APAC supply network.
• Technology Transfer & Manufacturing Site Transfers
• Lead the Quality workstream for technology…