Alcon are one of Korea ‘Top Employer’s’ and are the market leader in eye care globally, helping people see better through advanced surgical and vision care products and if you want to help make a difference then please join us!
Job Purpose
The Manager, Quality Assurance serves as the designated Responsible Pharmacist for imported pharmaceuticals in Korea. This role is responsible for ensuring compliance with Korean regulatory requirements and global quality standards while providing strategic leadership for product quality, batch release, quality systems, inspections, and supplier oversight. The position acts as the primary quality partner to Regulatory Affairs, Supply Chain, Commercial, Medical Affairs, and Global Quality functions to ensure uninterrupted supply of compliant products to the Korean market.
Major Accountabilities
Serve as the Responsible Pharmacist for imported pharmaceutical products.
Oversee deviations, investigations, CAPAs, change controls, risk assessments, supplier quality events, and complaints related matters.
Own batch disposition, import testing and final release of imported pharmaceutical and/or medical device products including review and approval of import testing results.
Drive quality system continuous improvement initiatives.
Ensure full compliance with MFDS regulations, GMP, GDP, applicable medical device/Pharmaceutical requirements, and internal quality policies.
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Lead preparation and management of Government inspections, corporate audits, and third-party audits.
Lead qualification and oversight of manufacturers, testing laboratories, warehouses, distributors, and service providers.
Manage recalls, field safety corrective actions, and quality-related regulatory reporting when required
Serve as quality business partner to local and global stakeholders.
Ideal Background
B.A Degree in Pharmaceuticals or other healthcare science
Licensed Pharmacist
Fluent in English
10 years of relevant experience in medical device and/or pharmaceutical industry
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Eligibility Requirements
No reason for disqualification on overseas business trip
Men are required or exempted from military service.
Information on returning employment documents
All applicants, except those who pass the final round, will be able to claim the return of the submitted employment documents during the period between 14 and 180 days from the date on which employment is confirmed.
In preparation for the applicant's request for return, we will keep the documents within 180 days after the announcement date of the final successful candidate, and the documents that have expired return period will be destroyed under the Personal Information Protection Act.
If the application is submitted on the website or by e-mail, or if the applicant submits it voluntarily without our request, it shall not be returned in accordance with the proviso to Article 11 (1) of the Fairness of the Employment Procedure Act, and if the employment documents are destroyed due to natural disasters or other reasons not liable to us, it shall be deemed to have been returned.
Applicants who wish to request the return of employment documents under the proviso to paragraph (1) submit a return request (Form 3 of the Enforcement Rules of the Act on the Fairness of Employment Procedures) by e-mail to the person in charge of employment and we send it to the designated address within 14 days from the date the submission is confirmed.
