Quality Manager APAC

PT Himalaya Wellness Indonesia; Jakarta Utara; On-site; IDR 600,000,000 - 900,000,000; Full time

Job summary

PT Himalaya Wellness Indonesia seeks an APAC Quality Leader to govern external manufacturing quality and supplier management across APAC. You will lead audits, CAPA, and risk management, ensuring GMP and regulatory compliance throughout transfers and transfers readiness.

You will establish the APAC quality framework, oversee technology transfer activities, and collaborate with R&D, Regulatory Affairs, Supply Chain and global quality to drive QMS improvements and supplier performance.

Qualifications

• Bachelor’s degree in pharmaceutical sciences or related field.
• Minimum 10 years of QA/QC experience in FMCG/Pharma.
• Strong hands-on external manufacturing/CMO QA management.
• Experience leading audits of external manufacturing and supplier sites.
• Experience with technology transfer between manufacturing sites.
• Knowledge of GMP, CAPA, change control, deviations, risk management.

Responsibilities

• Lead APAC Quality function and establish governance for external manufacturing and supplier network.
• Own QA/QA governance of APAC external manufacturing partners; qualification and onboarding through performance management.
• Establish supplier audit and quality surveillance programs based on risk.
• Lead technology transfer quality workstreams from other hubs to APAC external manufacturers.
• Ensure compliance with GMP, regulatory requirements and internal quality standards across APAC markets.
• Develop/APAC quality dashboard; provide data-driven quality reports to senior management.

Skills

QA Leadership

GMP Knowledge

Audit Management

Risk Management

Education

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field

Advanced degree or CQE/Six Sigma an advantage

Tools

SAP QM

Quality Systems

Job description

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

Willing to travel in APAC Countries