Position: Manager, Quality Assurance & Regulatory Affairs (QARA)

Working Location:

OMEGA 1 Bang Na, KM. 32-33, Bang Bo, Samut Prakan

Job Highlights

About the role

At ALP, quality and compliance are fundamental to how we operate. As Manager, Quality Assurance & Regulatory Affairs (QARA), you'll ensure our warehouse operations consistently meet customer expectations, regulatory requirements, and international quality standards.

You'll lead the development and continuous improvement of our Quality Management System (QMS), oversee regulatory compliance, and work closely with operations, customers, and regulatory bodies to maintain safe, efficient, and audit-ready logistics facilities. This role is especially important in supporting customers with regulated products such as pharmaceuticals, medical devices, healthcare, cold chain, and other quality-sensitive industries.

Job Responsibilities

What you will do...

Quality Management

Develop, implement, and continuously improve ALP's Quality Management System (QMS) across warehouse operations.

Establish and maintain Standard Operating Procedures (SOPs), work instructions, and quality documentation.

Ensure warehouse processes consistently meet customer requirements, quality standards, and operational best practices.

Monitor quality performance through KPIs, internal audits, inspections, and process reviews.

Lead root cause investigations and implement Corrective and Preventive Actions (CAPA) to drive continuous improvement.

Regulatory Affairs & Compliance

Ensure compliance with applicable regulatory requirements and industry standards, including Good Distribution Practice (GDP), ISO standards, and customer-specific requirements.

Manage regulatory audits, customer audits, certification audits, and inspections by government authorities.

Maintain warehouse licenses, certifications, permits, and regulatory documentation.

Monitor regulatory changes and assess their impact on warehouse operations, recommending appropriate actions.

Warehouse Quality Operations

Ensure warehouse operations follow approved procedures for receiving, storage, picking, packing, shipping, and returns.

Establish and monitor inventory control practices such as FIFO, FEFO, quarantine management, and batch traceability.

Oversee quality controls for temperature-controlled and cold chain operations, including temperature mapping, monitoring systems, and deviation management.

Ensure product integrity is maintained throughout storage and distribution activities.

Risk Management & Continuous Improvement

Conduct quality risk assessments and identify opportunities to strengthen operational controls.

Lead investigations into quality incidents, customer complaints, deviations, and non-conformities.

Develop and monitor CAPA plans to prevent recurrence and improve operational performance.

Support process improvement initiatives to enhance quality, compliance, and operational efficiency.

Training & Quality Culture

Develop and deliver quality and regulatory training programs for warehouse teams and cross-functional departments.

Promote a strong quality culture by embedding quality awareness into daily operations.

Coach operational teams on regulatory requirements, documentation practices, and quality standards.

Stakeholder Management

Partner closely with Operations, Customer Success, Business Development, Engineering, and Facility teams to ensure quality requirements are incorporated into daily operations.

Act as the primary quality representative for customers, auditors, certification bodies, and government agencies.

Support customer onboarding by ensuring warehouse operations meet contractual quality and compliance requirements.

Qualifications

Who you are

We are looking for a candidate with the following skills to manage the

main tasks:

Bachelor's degree in Quality Management, Industrial Engineering, Logistics, Supply Chain, or a related field.

10+ years of experience in Quality Assurance, Regulatory Affairs, or Quality Management within warehouse logistics, pharmaceutical logistics, medical devices, healthcare, FMCG, or related regulated industries.

Strong knowledge of warehouse quality systems, Quality Management Systems (QMS), and regulatory compliance.

Experience implementing or maintaining standards such as; Good Distribution Practice (GDP), ISO 9001, ISO 13485 (preferred), GMP or GSP (advantage)

Hands-on experience leading internal audits, external audits, and regulatory inspections.

Strong knowledge of CAPA, deviation management, risk assessment, document control, and change management.

Familiarity with Warehouse Management Systems (WMS), inventory traceability, and cold chain operations is an advantage.

Excellent analytical, problem-solving, and project management skills.

Good Command of Thai and English.

Quality-focused with a practical approach to solving operational challenges.

A strong communicator who can simplify complex regulatory requirements into practical ways of working.

Structured, detail-oriented, and highly organised.

Comfortable balancing operational efficiency with regulatory compliance.

A collaborative leader who builds trust across different teams and stakeholders.

Calm under pressure and confident leading audits and investigations.