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15 часов назад

Assistant QC Operations Manager (Pharmaceutical Quality)

Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
SK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Assistant QC Operations Manager (Pharmaceutical Quality): Managing quality operations for imported ophthalmology products in Korea with an accent on product testing, QMS governance, regulatory compliance, and supplier oversight. Focus on maintaining GMP/GDP/GSP compliance, supporting inspections and audits, and coordinating quality activities across laboratories, distributors, and logistics providers.

Location: Seoul, South Korea

Company

hirify.global is a Japan-originated life sciences company focused exclusively on ophthalmology, providing eye care treatments and digital solutions across more than 60 countries.

What you will do

  • Manage quality operations for imported products, including receiving inspections, shipment release approvals, import documentation, and defect investigations.
  • Coordinate product testing with approved contract laboratories and maintain accurate quality documentation.
  • Oversee warehouse, storage, and distribution quality activities, including GDP/GSP compliance, environmental monitoring, inventory handling, and product disposition.
  • Maintain and improve the local Quality Management System, including SOPs, training, deviations, CAPAs, change controls, risk assessments, quality metrics, and product quality reviews.
  • Provide quality oversight for suppliers, distributors, 3PL providers, contract manufacturers, and external laboratories.
  • Support regulatory inspections, audits, pharmacist surveillance, product launches, technology transfers, and product lifecycle changes.

Requirements

  • Bachelor’s degree in Pharmacy or a related scientific discipline; licensed pharmacist qualification is preferred.
  • At least 8 years of QA/QC experience in the pharmaceutical or medical device industry, including GMP manufacturing or commercial quality operations.
  • Strong knowledge of local regulatory requirements, GMP, GDP, GSP, and QMS for imported healthcare products.
  • Experience overseeing suppliers, distributors, 3PL providers, contract manufacturers, and external laboratories.
  • Experience supporting regulatory inspections, audits, pharmacist surveillance activities, and compliance initiatives.
  • Fluency in Korean and English is required; travel may be required for quality operations and audits.

Nice to have

  • Knowledge of PIC/S, ICH, and ISO standards.
  • Experience with cold chain management, analytical method transfer, and import or wholesale operations.

Culture & Benefits

  • Work within a global ophthalmology-focused life sciences organization with a long-term vision for improving outcomes for people with visual impairments.
  • Inclusive physical and virtual workplace.
  • Flexible ways of working.
  • Reasonable accommodation is available during the recruitment process.

Hiring process

  • Submit a resume using the provided format template.
  • Submit application materials in Korean and English, or in Korean.

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