Lead QA & Regulatory Affairs - HK/Macao

Leadingnation; Hong Kong; On-site; HKD 600,000 - 900,000; Full time

Job summary

Alcon, a global leader in eye care, seeks a primary QA lead to own QRA and GxP responsibilities in Hong Kong and Macao. You will manage local quality systems, ensure regulatory compliance, oversee distribution and product quality activities, and prepare for audits and inspections.

The role requires a BS in Life Science, at least 5 years QA/Regulatory Affairs experience, fluent English and Cantonese, and strong cross-functional collaboration.

Qualifications

• BS Degree in Life Science or related field; advanced degree preferred.
• Minimum 5 years of QA/Regulatory Affairs experience.
• Fluent in English and Cantonese (spoken and written).
• Strong cross-functional collaboration and communication skills.
• Proficient with standard software and document control systems.

Responsibilities

• Lead QA projects to improve performance and efficiency.
• Make operational decisions and perform QC on finished products.
• Monitor systems, conduct audits and inspections, and implement corrective actions.
• Serve as focal point for quality issues, ensuring regulatory compliance.
• Oversee quality systems at site, country, or regional level.
• Ensure adherence to GxP, maintain documentation, and complete trainings.
• Promote a Quality Culture and regulatory awareness as a strategic platform.
• Engage and motivate QA personnel through training and feedback.
• Manage non-conformance investigations, audit preparation, and external audits.
• Handle quality control activities and product complaints.

Skills

Quality Assurance

Regulatory Affairs

GxP compliance

Audit readiness

Education

BS in Life Science

Advanced degree preferred

Tools

Document control software

Job description

Alcon, a global leader in eye care, seeks a primary QA lead to own QRA and GxP responsibilities in Hong Kong and Macao. You will manage local quality systems, ensure regulatory compliance, oversee distribution and product quality activities, and prepare for audits and inspections.

The role requires a BS in Life Science, at least 5 years QA/Regulatory Affairs experience, fluent English and Cantonese, and strong cross-functional collaboration.