Quality Assurance Executive

About the Role

We are seeking a detail-oriented and proactive Quality Systems Executive to oversee and strengthen quality management and regulatory compliance within a highly regulated logistics environment. This role is ideal for professionals who are passionate about maintaining quality standards, driving process improvements, and ensuring compliance with industry regulations.

You will play a key role in supporting quality assurance initiatives across healthcare, pharmaceutical, medical device, and cold chain logistics operations. Working closely with cross-functional teams, you will help maintain an effective Quality Management System (QMS), coordinate audits, manage compliance activities, and contribute to operational excellence through continuous improvement initiatives.

Key Responsibilities

• Maintain and enhance the Quality Management System (QMS) to ensure ongoing compliance with regulatory and internal quality standards.
• Develop, review, and manage Standard Operating Procedures (SOPs), work instructions, quality policies, and controlled documentation.
• Oversee document control and records management to ensure accuracy, consistency, and compliance.
• Monitor quality performance indicators and prepare reports to support compliance and operational improvements.
• Drive continuous improvement initiatives that strengthen quality processes and overall business performance.
• Coordinate management review meetings and ensure timely completion of agreed follow-up actions.
• Support compliance with Good Distribution Practice (GDP), Good Distribution Practice for Medical Devices (GDPMDS), and other applicable regulatory requirements.
• Assist in customer quality programmes, certification activities, regulatory inspections, and surveillance audits.
• Manage quality events including deviations, non-conformances, corrective and preventive actions (CAPA), and change control processes.
• Conduct investigations into quality-related issues, perform root cause analysis, and recommend appropriate corrective measures.
• Handle customer quality enquiries, product complaints, and temperature excursion investigations while ensuring proper documentation and resolution.
• Participate in quality risk assessments relating to warehouse operations, storage conditions, and distribution activities.
• Coordinate internal, customer, supplier, and regulatory audits, ensuring audit findings are addressed within agreed timelines.
• Support supplier qualification activities, maintain supplier quality records, and monitor supplier performance.
• Contribute to business continuity, risk management, certification renewals, and other governance initiatives that support operational excellence.

Requirements

Essential

• Bachelor's Degree in Quality Management, Pharmaceutical Sciences, Engineering, Supply Chain Management, Life Sciences, or a related discipline.
• At least 3 years of relevant experience in Quality Assurance, Quality Systems, Regulatory Compliance, or Certification Management.
• Sound understanding of Quality Management Systems (QMS) and regulatory compliance requirements.
• Strong knowledge of CAPA, internal auditing, root cause analysis, risk management, and quality assurance practices.
• Ability to manage multiple priorities independently while maintaining high levels of accuracy and compliance.
• Experience coordinating audits, investigations, certification activities, and regulatory compliance programmes.

Preferred

• Experience within healthcare, pharmaceutical, medical device, cold chain logistics, contract logistics, or regulated warehouse operations.
• Familiarity with Good Distribution Practice (GDP) and Good Distribution Practice for Medical Devices (GDPMDS).
• Experience supporting external certification programmes, regulatory inspections, or customer compliance audits.
• Exposure to regulated warehousing, distribution environments, or logistics operations will be advantageous.

To Apply (via Harold Consultancy)

For a confidential discussion, please submit your detailed CV to Dennis Wee at [email protected].