Our strategic partner is a well-established pharmaceutical manufacturer with a strong commitment to quality, continuous improvement and global-standard compliance within the healthcare industry.
Location: Dong Nai, Vietnam
Job Responsibilities
- Lead the Quality Management System across the manufacturing site and ensure its continuous effectiveness.
- Develop, maintain and enforce Quality Policies and procedures aligned with international GMP standards.
- Build audit readiness and ensure the team is prepared for inspections by regulatory bodies and customers.
- Oversee product batch disposition to ensure only compliant products are released to market.
- Review and approve Quality System documentation within authorized scope.
- Monitor outsourced or contract manufacturing activities when applicable.
- Conduct annual Quality System and product performance reviews.
- Supervise internal audit execution and drive continuous compliance improvement.
- Represent the Quality function during external audits and assessments.
- Ensure corrective and preventive actions (CAPA) from audits are implemented on schedule.
- Maintain adherence to validation plans, SOPs, and regulatory compliance requirements.
- Oversee quality investigations and ensure timely closure of quality events.
- Manage change control processes with structured impact evaluation and completion follow-through.
- Monitor deviations and ensure root-cause corrective actions are effective and documented.
- Lead resolution of OOS, complaints, recalls and field quality issues as required.
- Make informed quality decisions relating to acceptance or rejection of materials and finished products.
- Evaluate and audit suppliers of raw materials or primary packaging in line with GMP expectations.
- Review and approve Quality Agreements with partners and third-party manufacturers.
- Identify process gaps and propose improvement initiatives to elevate system performance.
- Implement new quality procedures and ensure successful rollout within the organization.
- Develop Quality talent through coaching, training and competency building.
- Prepare and present Quality System performance reports to senior leadership.
- Maintain compliance with applicable regulatory standards and industry guidelines.
- Ensure timely investigation and response to product quality complaints.
- Promote safety, documentation integrity, confidentiality, and ethical compliance across the function.
- Build professional relationships with regulatory-aligned stakeholders to support product quality assurance.
Job Requirements
- Bachelor’s degree or higher in Pharmacy.
- 15+ years’ experience in pharmaceutical quality (QA/QC/regulatory/audit).
- Fluent English for professional communication.
- Strong understanding of EU GMP, EU GDP, WHO GDP, ICH Q9, EU Directive & WHO GMP/GSP/GLP
- Factory-based EU-GMP experience
- Proficient in Microsoft Office and digital documentation tools.
- Demonstrated leadership and team development capability.
- Strong problem-solving and decision-making skills.
- Effective communication and cross-functional collaboration.
- Skilled in time management and change management.
- Ability to train, coach, and develop team competency.
- High integrity, reliability, and accountability.
- Able to work under pressure with resilience.
- Positive, committed, improvement-driven mindset.
- Professional appearance and communication style.
If you possess the required skills and experience and are ready to significantly contribute to the dynamic team, we warmly welcome your application at tham.nguyen@peoplewise.vn or application@peoplewise.vn.
About PeopleWise Vietnam:
PeopleWise Vietnam was founded with the mission of positively impacting our community by improving the quality of the labor force, addressing workforce dynamics, and enhancing its effectiveness. During our initial phase, we provided solutions and human resources consulting services to our partners worldwide, including workforce advisory, organizational diagnosis, career transition, training services, talent management, and staffing solutions that align with each organization’s values and vision, driving business success.
Visit us at our website: https://peoplewise.vn/
To apply for this job email your details to tham.nguyen@peoplewise.vn