Regulatory Compliance Expert for Medical Devices and Pharmaceuticals

1 week ago


Hong Kong, Central and Western District, Hong Kong SAR China Allergan Full time

Job Overview

The Commercial Quality Specialist will play a critical role in ensuring the quality of pharmaceutical products, medical devices, combination products, biologics, and cosmetics. This position requires strong knowledge of local regulations, quality systems, and procedures to ensure compliance and efficiency.

Responsibilities

  • Integrate local quality regulations for drugs, biologics, device and/or combination products, and cosmetics.
  • Design quality systems, procedures, and processes within cross-functional teams to ensure compliance and efficiency.
  • Assess compliance to processes, procedures, and regulations to identify potential gaps and implement improvements.
  • Develop and approve quality documentation, including change controls and product reviews.
  • Support internal, external, and MoH audits, and lead self-inspections.
  • Investigate quality events, including deviations and non-conformances, and develop action plans.
  • Manage supplier qualification programs, including performance monitoring for key suppliers.
  • Monitor metrics and KPIs to ensure compliance.
  • Support Good Storage and Distribution Practices, including monitoring of controlled temperature and cold chain shipments.
  • Support the Management Review process for the affiliate.

Requirements

  • Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred.
  • 3+ years of experience in quality assurance, GMP, or GDP environment preferred.
  • Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault.
  • Full understanding of local GxP requirements, including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics, with an in-depth knowledge in one or more areas.
  • General knowledge and understanding of AbbVie MD, pharmaceutical, biologic, and cosmetic products and regulations.
  • Ability to support projects as a team member or lead as assigned by manager.
  • Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Makes decisions in collaboration with management.
  • Acts as an owner - uses available resources to independently complete assigned tasks.
  • Influencing - Understand your stakeholders and shape communication; can negotiate to win.
  • Personal Presence - Demonstrate the confidence that matches their subject matter expertise and intellectual capacity.


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