Quality Control Manager APAC (Based in Kelapa Gading)

Himalaya Wellness Indonesia; Jakarta Pusat; Presencial; IDR 90.000.000 - 130.000.000; Jornada completa

Descripción de la vacante

Himalaya Wellness Indonesia seeks a Quality Manager APAC to lead the quality function across APAC’s external manufacturing and supplier network. You will establish governance, drive audits, CAPA and risk management, and ensure GMP compliance for products and materials.

The role oversees technology transfers to APAC partners, ensuring readiness, validation and appropriate documentation, while coordinating with Regulatory, Supply Chain and Global Quality teams.

Formación

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Food Science, Engineering or related field.
• Minimum 10 years of QA/QC experience in FMCG, healthcare, pharmaceuticals or related industry.
• Strong hands-on external manufacturing/CMO quality mgmt experience.

Responsabilidades

• Lead APAC Quality Leadership & Governance and establish a governance framework for external manufacturing and suppliers.
• Own QA governance from qualification to ongoing performance management of external partners.
• Lead audits, CAPA, risk-based qualification and timely remediation across APAC network.
• Drive technology transfer quality plans, readiness, validation and documentation for transfers into APAC partners.
• Collaborate with Regulatory Affairs, Supply Chain and R&D to ensure compliant product launches and transfers.

Conocimientos

Quality leadership

External manufacturing quality

Auditing

CAPA

Technology transfer

Supplier quality management

GMP

Risk management

Project management

Educación

Bachelor's degree in Pharmaceutical Sciences

Herramientas

SAP QM

QMS systems

Descripción del empleo

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.

Key Responsibilities

• 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 transfers from manufacturing sites in other hubs to APAC external manufacturing partners.
• Ensure transfer plans adequately address product, process, analytical, specification, documentation, validation and regulatory requirements.
• Assess transfer readiness of receiving external manufacturers and identify and close quality gaps before commercial manufacture.
• Coordinate with sending sites, R&D, Regulatory Affairs, Supply Chain and external manufacturers to ensure effective transfer of product and process knowledge.
• Ensure appropriate qualification, validation, technical documentation, change control and quality approvals are completed before transfer closure.
• Monitor trials, scale up, validation and post-transfer quality performance and ensure any issues are appropriately investigated and resolved.
• Regulatory, GMP & Quality Compliance
• Ensure external manufacturing and supplier quality systems comply with applicable local market regulations, GMP requirements, relevant certifications and company quality standards.
• Maintain awareness of changes in regulatory and quality requirements across APAC markets and ensure relevant requirements are incorporated into the quality system.
• Partner with Regulatory Affairs to ensure quality requirements are appropriately reflected in product launches, transfers, changes and ongoing commercial operations.
• Support regulatory inspections and other external compliance activities involving external manufacturing and supplier partners.
• Ensure quality documentation, records and evidence are complete, current, controlled and inspection-ready.
• Quality Systems, Risk Management & Continuous Improvement
• Maintain effective quality systems covering deviations, CAPA, change control, complaints, quality risk management, audit management and document control as applicable to the APAC network.
• Establish risk-based quality assessments for external manufacturers, critical suppliers, products and processes.
• Maintain appropriate quality risk registers and ensure material risks have clear mitigation and escalation plans.
• Analyze quality data and trends to identify systemic issues and improvement opportunities.
• Lead continuous improvement initiatives that strengthen quality, compliance, reliability and effectiveness across the external supply network.
• Promote prevention-focused quality management rather than relying solely on detection and corrective action.
• Product Quality Incidents, Complaints & Escalation
• Provide quality leadership for significant product quality issues, deviations, consumer complaints, non-conformities and potential product incidents involving external partners.
• Ensure investigations are appropriately scoped, scientifically and factually supported, and completed within defined timelines.
• Ensure robust root-cause analysis, CAPA and effectiveness checks are implemented for significant quality events.
• Support cross-functional assessment of potential product withdrawal or recall situations and ensure appropriate quality escalation.
• Ensure lessons learned from quality incidents are incorporated into supplier, manufacturer and process improvement plans.
• Documentation, Metrics & Management Reporting
• Oversee quality documentation, SOPs, quality agreements, audit reports, validation/transfer documentation and quality records relevant to the APAC network.
• Develop and maintain a meaningful APAC Quality dashboard covering external manufacturing, suppliers, audits, CAPA, deviations, complaints, compliance and emerging risks.
• Use quality data and trends to provide fact-based recommendations to Supply Chain and senior management.
• Ensure timely escalation of critical issues and transparent reporting of quality risks and performance.
• Cross-Functional & Stakeholder Management
• Work closely with Supply Chain, Procurement, R&D, Regulatory, Global Quality, Commercial and other functions to embed quality into business decisions.
• Build strong working relationships with external manufacturers, suppliers and manufacturing hubs in other regions.
• Represent APAC Quality in relevant regional and global governance forums. Connect with Global and India Quality team on an ongoing basis.
• Influence external partners and internal stakeholders to deliver sustainable quality improvements without compromising compliance requirements.

Qualifications & Experience

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Food Science, Engineering or another relevant scientific/technical discipline. Advanced degree or relevant professional certification such as CQE or Six Sigma is an advantage.
• Minimum 10 years of relevant experience in Quality Assurance/Quality Control within FMCG, Consumer Health, Healthcare, Pharmaceuticals or a closely related regulated industry.
• Strong hands-on experience in external manufacturing/CMO quality management and supplier quality management.
• Demonstrated experience conducting or leading audits of external manufacturing and supplier sites.
• Proven experience in technology transfer, preferably involving transfer between manufacturing sites, hubs or external manufacturing partners.
• Strong knowledge of GMP, quality management systems, CAPA, change control, deviations, quality risk management and audit management.
• Experience working across multiple APAC markets and understanding of market-specific quality and regulatory requirements.
• Experience with SAP Quality Management (QM) or comparable ERP/QMS systems is preferred.
• Experience supporting regulatory inspections or compliance assessments is preferred.
• Indonesian Bahasa and Mandarin language proficiency is preferred, together with strong English communication skills.

Core Skills & Capabilities

• Strong quality leadership and governance capability.
• Deep understanding of external manufacturing and supplier quality models.
• Strong auditing, investigation, root-cause analysis and CAPA capabilities.
• Strong technology transfer and project management skills.
• Risk-based decision making and ability to identify and escalation critical quality risks.
• Strong analytical capability, including interpretation of quality trends and performance data.
• Excellent stakeholder management and influencing skills, particularly with third-party partners.
• Ability to operate effectively across countries, cultures, functions and organizational boundaries.
• High level of integrity, attention to detail and commitment to quality and compliance.
• Proactive, pragmatic and results-oriented approach, with the ability to balance business requirements with non-negotiable quality standards.

Personal Attributes

• Strategic and systems-oriented, while comfortable operating at detailed operational level when required.
• Independent and confident in challenging external partners and internal stakeholders on quality matters.
• Collaborative, pragmatic and commercially aware without compromising quality or compliance.
• Proactive, resilient and comfortable managing ambiguity and complex cross-functional situations.
• Strong ownership mindset with a focus on prevention, sustainable corrective action and continuous improvement.

Travel Requirements

Full-time position based in Jakarta, Indonesia. The role will require regular travel within APAC and, as required, to China and other manufacturing hubs, external manufacturing sites, supplier sites and other company locations for audits, technology transfers, quality reviews and critical quality matters.

Key Measures of Success

• Compliance and quality performance of the APAC external manufacturing and supplier network.
• Successful qualification and ongoing performance of critical external manufacturing and supplier partners.
• Timely and effective closure and effectiveness of audit findings and CAPA.
• Successful execution of technology transfers into APAC external manufacturing sites.
• Reduction in recurring quality issues, significant deviations, complaints and supplier/CMO-related quality failures.
• Visibility and timely escalation of material quality risks to APAC and global management.
• Continuous strengthening of quality systems, supplier capability and network resilience.