The Quality Assurance Specialist is responsible for supporting and maintaining quality and regulatory compliance for pharmaceutical and medical device operations in Korea by performing the duties and responsibilities outlined below.

Responsible for preparation of Documentation for release of Drug & PD Medical Device.

• Perform and manage product release, labeling processes for pharmaceuticals and medical devices, and the product hold system.
• Lead and manage analytical method transfers and local testing activities for pharmaceuticals in Korea.
• Perform and manage field actions, including communication with internal and external stakeholders and timely reporting to the Ministry of Food and Drug Safety (MFDS).
• Perform and manage product complaint handling activities for products marketed in Korea and provide complaint and vigilance training to employees.
• Ensure timely post-market reporting of medical device adverse events to the MFDS.
• Conduct gap analyses of global and APAC regional quality documents and requirements.
• Manage and maintain local quality documents, including SOPs, manuals, APQRs, and product master files.
• Maintain pharmaceutical and medical device business licenses and KGMP certifications, and prepare related documentation.
• Perform QMS activities and other quality-related responsibilities for the Korea General Office (GO), and support internal, external, and regulatory audits.
• Perform and manage change control activities.
• Support local training programs and monitor training compliance in Korea.
• Perform quality-related activities for warehousing operations and ensure the quality of services and processes provided by 3PL providers, distributors, contractors, and other third parties.
• Support the maintenance of GMP and Good Warehousing Practices (GWP), and implement quality system improvements in accordance with MFDS regulations and corporate requirements.
• Collaborate closely with Regulatory Affairs (RA) within the RAQA team, as well as with Business Units, Fulfillment, Planning, and other cross-functional teams

Qualifications:

• 5–10 years of Quality Assurance experience in the healthcare industry is required. Pharmaceutical industry experience is essential.
• Knowledge of applicable regulations and standards, including GMP and Korean pharmaceutical and medical device regulations.
• Strong written and verbal communication skills in both Korean and English.
• Demonstrates confidence when challenged, clearly articulating the rationale for own viewpoints while listening to and respecting differing opinions.
• Strong interpersonal and influencing skills, with the ability to adapt communication styles to different audiences to ensure effective collaboration.
• Demonstrates organizational awareness and experience working in cross-functional teams, with a proven ability to build and maintain collaborative relationships across functions and with key stakeholders.

Education and/or Experience:

• Bachelor's degree is required, preferably in a scientific discipline, Business Administration, Industrial Engineering, or a related field.
• A minimum of 5 years of experience in pharmaceutical and/or medical device GMP/QSR quality management is required.
• An advanced degree is preferred.