Head of QA (Open for both Vietnamese and Expat)

• Lead the Quality Operations, Quality Systems & Continuous Improvement, and Quality Compliance functions, ensuring effective Quality Assurance (QA) oversight across the site and adherence to regulatory requirements and global quality standards.
• Develop, implement, and maintain QA strategies and quality systems to ensure compliance with GMP, GLP, cGMP, and relevant regulatory requirements (DAV, EU, WHO, and ICH guidelines).
• Provide technical leadership and quality support for manufacturing operations, ensuring product quality, compliance, and operational excellence.
• Review and approve critical quality documents, including Site Master Files (SMF), Validation Master Plans (VMP), Quality Manuals, SOPs, protocols, reports, and other GMP documentation, ensuring compliance with applicable regulations and company standards.
• Ensure timely review and approval of batch records, validation documentation, product quality reviews, and other quality-related records.
• Lead investigations of product quality issues, deviations, complaints, and non-conformances, ensuring robust root cause analysis and effective implementation of Corrective and Preventive Actions (CAPA).
• Review and approve major deviation and non-conformance investigation reports, ensuring timely resolution and regulatory compliance.
• Manage and continuously improve key Quality Systems, including Document Control, Deviation Management, CAPA, Change Control, Risk Management, Training, and Quality Metrics.
• Lead internal audits, self-inspections, and readiness activities for external audits, customer audits, and regulatory inspections.
• Support the Site Quality Head during global quality audits and inspections conducted by regulatory authorities and customers, including EU, DAV, and emerging market agencies.
• Collaborate with cross-functional stakeholders to drive compliance, operational effectiveness, and a culture of quality across the organization.
• Champion continuous improvement initiatives to enhance quality systems, processes, product quality, and regulatory compliance.
• Oversee the compilation, analysis, and presentation of QA performance metrics and quality data for Monthly Business Reviews (MBR) and Quality Management Business Reviews (QMBR).
• Lead people management activities, including workforce planning, performance management, training and development, succession planning, and team engagement, fostering a high-performing quality culture.
• Manage QA budgets, resource allocation, and quality improvement projects to ensure effective utilization of resources and achievement of business objectives.
• Participate actively in Quality Council and governance meetings, driving compliance initiatives, sharing best practices, and supporting strategic quality improvements.
• Leverage digital quality platforms and systems, including Electronic Quality Management Systems (eQMS), Electronic Document Management Systems (eDMS), SAP, and LIMS, to improve efficiency, compliance, and data integrity.
• Provide support for regulatory submissions, compliance initiatives, quality projects, and other responsibilities as assigned by the Site Quality Head.

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 15 years of experience in Pharmaceutical Quality Assurance, including at least 5 years of leadership or senior management roles within highly regulated pharmaceutical manufacturing environments.
• Proven experience supporting and overseeing quality activities for both Solid Oral Dosage (OSD) and Sterile Manufacturing Operations.
• Additional experience in Quality Control (QC) and Computerized System Validation (CSV) is considered a strong advantage.
• Demonstrated experience working within US FDA and/or EU-approved pharmaceutical facilities, including the management of Quality Systems, compliance programs, and QA teams.
• Extensive knowledge of GMP, GLP, cGMP, ICH guidelines, regulatory requirements, data integrity principles, and Computerized System Validation (CSV) applicable to pharmaceutical manufacturing.
• Proven track record in leading and supporting regulatory inspections and audits conducted by authorities and customers, including US FDA, EU, WHO, and other international regulatory agencies.
• Strong leadership capabilities with excellent communication, stakeholder management, decision-making, and problem-solving skills.
• Proficiency in digital quality and business systems, including Electronic Quality Management Systems (eQMS), Electronic Document Management Systems (eDMS), SAP, LIMS, QC software, and other digital compliance platforms.
• Strong command of English, both written and verbal; proficiency in Vietnamese is considered an added advantage.
• Demonstrated ability to work effectively with cross-functional teams, senior leadership, and global stakeholders across multiple sites and regions.
• Excellent interpersonal skills with the ability to communicate, influence, and build strong working relationships at all organizational levels and across diverse cultures and personalities.

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