Quality Compliance Manager

We are partnering with a leading Pharmaceutical MNC and in the search for a Quality Compliance Manager. This role involves maintaining the quality system in accordance with GDP and corporate guidelines to ensure regulatory compliance and the implementation of quality policies and objectives. The manager will oversee quality supervision and operations related to product quality, safety, and compliance in the Hong Kong OPU.

Responsibilities

1. Quality Management System

   • Maintain and implement the quality management system.
   • Manage batch disposition and technical complaint management.
   • Oversee product change control, deviations, events, and complaints.
   • Lead market actions and mock recalls for the Hong Kong market.
   • Participate in quality risk management and quality management reviews.

2. Discrepancy Management

   • Act as the local management system owner for discrepancies (Deviation/CAPA).
   • Coordinate record management using Trackwise and Vault systems.
   • Manage temperature and logistical issues with inbound deliveries.

3. Supplier and Document Management

   • Support the management of suppliers and distributors in Hong Kong.
   • Participate in the qualification of new suppliers.
   • Oversee training management and document lifecycle management.
   • Conduct gap analysis of SOPs to ensure compliance with corporate regulations.

Requirements

• Bachelor’s degree in pharmacy, bioscience, or a relevant discipline.
• Minimum 3 years of experience in Quality Management within the pharmaceutical industry.
• Knowledge of GSP/GDP laws and requirements.
• Strong communication, collaboration, and leadership skills.
• Ability to ensure effective quality management and team performance.