Senior Manager, Quality Assurance & Regulatory Affairs

About the role

An established healthcare and pharmaceutical organization in Hong Kong is seeking a senior leader to head its Quality Assurance and Regulatory Affairs function. The role combines strategic oversight of regulatory compliance, quality systems, and pharmacovigilance with direct partnership with commercial and operational teams.

Key responsibilities

• Lead the QA & RA function, ensuring compliance with local and international regulations.
• Manage product registrations, renewals, variations, and submissions for pharmaceutical and healthcare products.
• Act as primary liaison with regulatory authorities on licensing and compliance matters.
• Oversee quality management systems and maintain relevant certifications.
• Support secondary packaging operations and ensure regulatory adherence.
• Maintain accurate regulatory documentation, licenses, and records.
• Partner with cross‑functional teams to drive quality initiatives, risk management, and continuous improvement.
• Ensure effective pharmacovigilance processes in line with local requirements.
• Lead, mentor, and develop a high‑performing QA/RA team.
• Contribute to business‑critical projects and strategic initiatives as needed.

Required profile

• Bachelor's degree in Pharmacy or a related life‑science discipline.
• Solid experience in Regulatory Affairs and Quality Assurance within pharmaceutical, medical device, or healthcare industries.
• Proven people‑management and leadership experience.
• Strong knowledge of Hong Kong healthcare regulations and product registration processes.
• Familiarity with quality management systems and compliance standards.
• Excellent communication and stakeholder‑management skills.
• Fluency in English, Cantonese, and Mandarin.