Quality Management System Manager (Pharma)

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.

• 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.