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About the Role

The SOQ - Quality Manager will establish, maintain, and implement the Quality Management System (QMS) at Pfizer Country Offices (PCOs) to ensure compliance with Pfizer and Regulatory Authority expectations. This role involves working closely with local stakeholders to ensure appropriate quality standards and systems are in place for product supply operations and may involve being named as a Responsible Person/Pharmacist on the Pfizer Drug License for Wholesale.

Responsibilities

• 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, confirming all requirements are met prior to distribution.
• Decide on the final disposition of returned, rejected, recalled, or falsified products.
• Manage Quarantine Alert Notifications promptly.
• Coordinate and perform market action or recall operations promptly.
• Participate in Area Quality Review Team (AQRT) or enhance Site Quality Review Team (eSQRT) meetings as PCO representative, providing local assessment and contributing to executive summaries.
• Ensure implementation of local actions identified during AQRT or eSQRT.
• Serve as the primary quality liaison with local health authorities for imported product release, quality issues, supplier and logistics partner oversight, and regulatory inspections.
• Ensure 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.
• Ensure initial and continuous training programs are implemented and maintained for relevant PCO colleagues.
• Ensure planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately, with actions completed as per agreed timelines.
• Ensure deviations from Product Quality and Compliance requirements are investigated thoroughly and within required timelines.
• Ensure relevant customer complaints are dealt with effectively, performing intake and issuing correspondence.
• Act as a contact point for Regulatory Agency/reporter in the PCO.
• Manage relevant corrective and preventative actions (CAPA).
• Ensure timely completion of the local MAH review of the Annual Product Quality Review (APR).
• Ensure 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.
• Monitor key quality performance indicators, evaluate trends, and identify actions for process improvements.
• Ensure Quality Review Meetings are conducted.
• Provide on-going education on Quality to relevant PCO functional groups to increase awareness and enhance the Quality Culture.
• Keep appropriate records of any delegated duties.
• Work with local cross-functional teams to define action plans for inspection/audit observations and track implementation.
• Lead self-inspections at defined intervals.
• Ensure a program is in place for the consistent application, documentation, and communication of risks to product quality/patient safety.
• Ensure the compliant management and maintenance of suppliers using a lifecycle management approach.
• Provide oversight of supplier and logistics partner management, including qualification, quality agreements, performance monitoring, and issue resolution.

Requirements

• 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 stakeholders and external parties.
• Experience in GMP, GDP, GLP, GSP and QMS.
• Technical writing and reporting skills.
• Substantial experience in Quality market affiliates, pharmaceutical manufacturing.
• Familiarity with Current Good Manufacturing Practices (cGMP and KGMP) and handling compliance issues.
• 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.
• 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.

Skills

• Quality Management System (QMS)
• GMP
• GDP
• GLP
• GSP
• cGMP
• KGMP
• Technical writing
• Reporting
• MS Office applications
• PDM
• Quality Tracking System
• Documentum platforms
• AI tools (ChatGPT, Microsoft Copilot)
• Leadership
• Team management
• Influencing
• Negotiation

Location

• Korea

Work Type

• Hybrid
• Full-time

Experience Level

• 7+ years in pharmaceutical industry quality role

Education Level

• BA/BS with Pharmacy degree
• Korean Pharmacist License

About the Company

• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Equal Opportunity

• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.