QA Lead

Job Qualification:

• Bachelor’s degree in Biology, Biomedical Science/Engineering, Pharmacy, Chemistry, Chemical/Industrial Engineering, or other related disciplines.
• Minimum 4 years of experience in Quality Assurance, Quality Management System, or laboratory operations, with at least 2–3 years in a supervisory or lead role.
• Experienced in implementing and maintaining ISO 9001 and/or ISO 17025 systems, including audit preparation and certification processes.
• Familiar with regulatory licensing and compliance requirements under relevant government institutions such as the Ministry of Health and other related authorities.
• Good understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and risk-based quality management principles.
• Proficient in Google Workspace (Sheets, Docs, Slides) and/or Microsoft Office (Excel, Word, PowerPoint), and familiar with project management or quality management tools.
• Strong leadership, communication, interpersonal, and coordination skills, with the ability to work effectively in a cross-functional environment.
• Highly organized, detail-oriented, proactive, and able to manage multiple priorities effectively.
• Possess strong analytical thinking and problem-solving skills.
• Demonstrate high integrity, honesty, and accountability in daily work activities.

Job Description:

• Lead the implementation, maintenance, and continuous improvement of the Company’s Quality Management System (QMS), including ISO 9001, ISO 17025, ISO 13485, and ISO 15189 scopes as required by business needs.
• Ensure effective document and record control through the Document Management System (DMS), including SOPs, policies, forms, and quality records.
• Oversee quality assurance processes including risk management, change control, deviation handling, CAPA management, and internal audit programs to ensure compliance and process consistency.
• Ensure compliance with applicable regulations, quality standards, and customer requirements, and maintain readiness for internal and external audits.
• Coordinate with regulatory bodies, certification agencies, auditors, and clients regarding audits, inspections, and corrective action follow-ups.
• Monitor and analyze Quality KPIs, non-conformities, audit findings, and improvement initiatives to support management review and decision-making.
• Collaborate with cross-functional teams to ensure quality requirements are effectively implemented across company operations.
• Lead and develop the QA team through performance management, competency development, coaching, and training programs.
• Drive continuous improvement initiatives to enhance quality systems, operational efficiency, and compliance effectiveness.