The SOQ - Quality Manager will be responsible for establishing, maintaining, and implementing the Quality Management System (QMS) at the Pfizer Country Offices (PCOs) to ensure compliance with both Pfizer and Regulatory Authority expectations.
Act as the designated Responsible Person (RP) for imported medicinal products in Korea, ensuring ongoing compliance with MFDS, KGMP, and GDP regulatory requirements and Pfizer quality standards.
Conduct quality review and authorize market release of imported products under the PCOs importer and distribution license, confirming that all regulatory, technical, and Pfizer requirements are fully met prior to distribution and commercial supply.
Decides on the final disposition of returned, rejected, recalled or falsified products.
Manages Quarantine Alert Notifications promptly.
Coordinates and performs any market action or recall operation promptly.
Notification to Management – participates in Area Quality Review Team (AQRT) or enhance Site Quality Review Team (eSQRT) meetings as PCO representative and provide the local assessment on the subject. Contributes to AQRT or eSQRT Executive Summary for issues originating under the responsibility of the PCO. Ensure implementation of local actions identified during the AQRT or eSQRT.Serve as the primary quality liaison with local health authorities for matters related to imported product release, quality issues, supplier and logistics partner oversight, regulatory inspections, and follow‑up actions.
Ensures timely implementation of all applicable quality management systems (SOPs) within the PCO.
Assess new quality system/local regulatory requirements and adjust/enhance local systems and processes when required.
Ensures that initial and continuous training programs are implemented and maintained for all relevant PCO colleagues.
Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately. Ensures change actions are completed as per agreed timelines.
Deviation Management – ensures deviations from Product Quality and Compliance requirements that occur within the responsibility of the PCO are investigated thoroughly and within required timelines.
Complaint Handling – ensures that relevant customer complaints are dealt effectively. Perform Intake, issue correspondence letter as required. Acts as a contact point for Regulatory Agency/reporter in the PCO.
Management of relevant corrective and preventative actions (CAPA).
Annual Product Quality Review (APR) - Ensure timely completion of the local MAH review of the APR.
Ensures a compliant process is in place to manage quarantine shipments.
Lead the Quality Management Review (QMR) process, ensuring systematic review of quality performance, risks, compliance status, and continual improvement actions for imported products.
Monitors key quality performance indicators on the PCOs quality performance, evaluates and highlights any significant trends and identifies actions, opportunities to propose improvements to the processes. Ensure Quality Review Meetings are conducted.
Provides on-going education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and to enhance the Quality Culture.
Keep appropriate records of any delegated duties, if required.
Work with local cross functional team to define appropriate action plans to address the inspection/audit observation and tracks action implementation within the agreed timelines.
Lead self-inspections are performed at defined intervals following a pre-arranged program.
BA/BS with Pharmacy degree, Korean Pharmacist License is required
A minimum of 7 years in the pharmaceutical industry in a quality role.
Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties.
Experience in GMP, GDP, GLP, GSP and QMS.
Technical writing and reporting.
Substantial experience in Quality market affiliates, pharmaceutical manufacturing
Familiarity with Current Good Manufacturing Practices (cGMP and KGMP) and handling compliance issues arising from cGMP deviations or product defects
Knowledge of regulations related to vendor management programs and other industry quality systems
Strong critical thinking skills and a proactive approach
Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System, and Documentum platforms
Fluent in English (written & verbal),
Fluent in Korean (written & verbal)
Experience using common AI tools such as ChatGPT or Microsoft Copilot
Strong leadership and team management skills
Ability to work under pressure and meet tight deadlines
Ability to influence and negotiate with stakeholders
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