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6 дней назад

QA Manager (Pharmaceutical Quality)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
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
QA Manager (Pharmaceutical Quality): Managing compliant quality operations for pharmaceutical and medical device importation, testing, repackaging, storage, release, and distribution in Korea with an accent on regulatory compliance, GDP/GDPMD, and local Quality Management System maintenance. Focus on coordinating audits and inspections, resolving deviations and product quality issues, overseeing suppliers and service providers, and managing cold-chain and local testing requirements.

Location: Seoul, South Korea

Company

hirify.global is a Japan-originated global life sciences company focused exclusively on ophthalmology, innovative eye care treatments, and digital solutions.

What you will do

  • Manage quality operations for importation, local testing, repackaging, storage, shipment, release, and distribution activities in Korea.
  • Support the implementation, maintenance, and continuous improvement of the local Quality Management System and act as deputy Quality Management Representative.
  • Coordinate quality activities with Supply Chain, Regulatory Affairs, Safety Vigilance, commercial stakeholders, distributors, warehouses, laboratories, and other service providers.
  • Oversee product receipt, warehousing checks, batch and shipment release support, temperature excursion assessments, deviations, CAPA, and product quality issues.
  • Plan and execute internal, supplier, regulatory, and certification audits, including inspection readiness and follow-up actions.
  • Provide quality input for new product introductions, launches, product variations, supply continuity, and other local and global quality initiatives.

Requirements

  • Science degree and certification as a pharmacist in Korea.
  • 10–12 years of experience in pharmaceutical and/or medical device quality functions, including commercial quality operations, GDP/GDPMD, local testing, importation, storage, release, and distribution.
  • Experience with Korean regulatory requirements, local product testing, secondary packaging, distributors, audits, inspections, and external service provider oversight.
  • Knowledge of cGMP and quality systems and guidelines such as PIC/S, ICH, ISO 9001, or ISO 13485, including cold-chain product repackaging.
  • Ability to manage complex priorities, projects, timelines, compliance risks, stakeholder coordination, and escalation in a matrix environment.
  • Strong interpersonal, negotiation, teamwork, communication, and follow-up skills; fluent English and Korean are desired.

Culture & Benefits

  • Work in a global ophthalmology-focused life sciences organization with operations across more than 60 countries.
  • Flexible ways of working and an inclusive physical and virtual workplace.
  • Cross-functional and cross-cultural collaboration across regional and global quality teams.
  • Opportunity to contribute to initiatives addressing vision-related social and economic needs.

Hiring process

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

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