Senior QA & Regulatory Affairs Lead (HK/Macau)

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

Job summary

Alcon in Hong Kong seeks a primary Quality Assurance lead for QRA and GxP in HK and Macao. You will independently manage the local quality system, compliance, and third-party quality oversight, collaborating with regional RA resources.

You will drive audits, document control, training, and continuous improvement, shaping a strong quality culture across the site and ensuring product safety and regulatory readiness.

Qualifications

• Minimum BS Degree in Life Science or related field.
• Minimum 5 years of QA experience.
• Fluent in English and Cantonese, both spoken and written.
• Strong computer literacy and documentation skills.
• Knowledge of QA and Regulatory Affairs requirements.

Responsibilities

• Lead QA projects and ensure regulatory compliance.
• Oversee local quality system, GxP compliance, and audits.
• Coordinate regulatory affairs activities with regional/global RA.
• Manage non-conformances, investigations, and CAPAs.
• Ensure training, documentation, and audit readiness.
• Promote quality culture and cross-functional collaboration.

Skills

Quality Assurance

Regulatory Affairs

GxP compliance

Audit & Inspection

Quality Culture

Cross-functional collaboration

English

Cantonese

Education

BS Degree in Life Science

Advanced degree preferred

Job description

Alcon in Hong Kong seeks a primary Quality Assurance lead for QRA and GxP in HK and Macao. You will independently manage the local quality system, compliance, and third-party quality oversight, collaborating with regional RA resources.

You will drive audits, document control, training, and continuous improvement, shaping a strong quality culture across the site and ensuring product safety and regulatory readiness.