Quality Sytems Executive
Summary
Oversee quality systems and regulatory compliance for a logistics company handling healthcare, pharmaceutical, and medical device shipments, ensuring adherence to strict standards like GDP and GDPMDS.
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 recruit@haroldconsultancy.com.