6 дней назад
QA Manager (Pharmaceutical Quality)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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