Regional Manager, Quality Assurance

We're partnering with a fast-growing pharmaceutical manufacturing company in APAC, with the commercialization rights of 1 under development innovative drug and 7 originator drugs in primary healthcare that are originally from global top 500 MNCs. They're currently looking for a Regional Manager, Quality Assurance to join their expanding team in Hong Kong!

Job Description:
Responsible for the quality management of the company's internationally marketed products. This includes establishing and maintaining the international business quality management system, managing quality activities at CMO (Contract Manufacturing Organization) factories and in the markets where the products are sold, ensuring compliance with GMP (Good Manufacturing Practices) and related regulatory requirements in the product sales regions.

Responsibilities:

• Establish and maintain basic quality systems based on GMP and relevant regulatory requirements in the product's marketed regions
• Responsible for establishing and maintaining quality documentation for international products, including but not limited to quality standards, analytical methods, batch production and packaging records, analytical method validation, process validation, and cleaning validation, etc.
• Manage the quality activities of CMO factories and in the marketed regions, including but not limited to: handling major and critical deviations related to product quality, OOS (Out of Specification) / OOT (Out of Trend), medium and above level changes, on-site audits and qualification of CMOs and key suppliers, quality agreements with CMOs and major material suppliers, product quality reviews, and providing the necessary document support for product sales in marketed regions
• Assist with and supervise GMP and regulatory compliance in CMO factories and marketed regions, including document support and submissions
• Responsible for product release in the marketed regions and handling in the SAP system
• Review and approve packaging designs, release them for use in CMO factories, and manage version control
• Oversee product transportation and storage for market sales, assist with handling complaints and recalls, and support adverse reaction investigations
• Monitor product stability and ongoing stability studies

• Bachelor's degree in Pharmacy, Chemistry and Biomedical Science or related fields
• At least 8 years of practical experience in pharmaceutical production and quality management
• Experience working in multinational or foreign pharmaceutical companies is preferred
• Expertise in solid dosage form production and quality management
• Familiarity with, FDA cGMP, EU GMP, and other related regulations and technical guidelines
• Strong communication, organizational, coordination, and project management skills
• Fluent in both written and spoken Chinese and English, with good writing