Quality Manager (Pharmaceuticals)

TL;DR

Quality Manager (Pharmaceuticals): Establishing and implementing the Quality Management System (QMS) for hirify.global Korea with an accent on regulatory compliance and product supply operations. Focus on managing market release, coordinating recall operations, and ensuring adherence to KGMP and GDP standards.

Location: Hybrid (Seoul, South Korea)

Company

Global pharmaceutical leader dedicated to breakthroughs that change patients' lives.

What you will do

• Act as the designated Responsible Person (RP) for imported medicinal products in Korea, ensuring compliance with MFDS and KGMP.
• Authorize market release of imported products and decide the final disposition of returned, rejected, or recalled products.
• Serve as the primary quality liaison with local health authorities regarding product release, quality issues, and regulatory inspections.
• Implement and maintain QMS, SOPs, and continuous training programs for all relevant PCO colleagues.
• Manage deviations, customer complaints, CAPAs, and conduct Annual Product Quality Reviews (APR).
• Provide oversight of supplier and logistics partner management, including qualification and performance monitoring.

Requirements

• BA/BS with Pharmacy degree and a valid Korean Pharmacist License is required.
• Minimum 7 years of experience in the pharmaceutical industry in a quality role.
• Expertise in GMP, GDP, GLP, GSP, and QMS.
• Fluency in both English and Korean (written and verbal).
• Familiarity with cGMP and KGMP and experience handling compliance issues.
• Proficiency in MS Office and enterprise systems such as PDM, Quality Tracking System, and Documentum.

Nice to have

• Experience using common AI tools such as ChatGPT or Microsoft Copilot.

Culture & Benefits

• Hybrid work location assignment.
• Commitment to equal opportunity employment and diversity.
• Professional growth within a leading global healthcare corporation.