[한국 화이자제약] Medical Quality Governance Specialist(1-yr contract) 채용

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한국 화이자제약에서

Medical Quality Governance Specialist 계약직을 모집 합니다.

[Quality Management] 

• Drive Level 1 medical quality oversight and business support at the market level. 
• Lead the development of country medical quality strategic initiatives based on risk and business needs, in close collaboration with local medical management, IMQG, and other key stakeholders (e.g., Platform Line management [Safety, Regulatory]). 
• Execute Global Quality Plans. Develop and maintain Country Operational Plans as applicable. 
• Demonstrate MQG value proposition to internal stakeholders and external customers.  
• Quality Consulting activities (e.g., answer to queries on medical quality requirements). 
• Conduct a Self-inspection for safety management activities periodically (e.g., on a yearly basis) in accordance with local regulations (e.g., Enforcement Rule on Safety of Medicinal products).

[Audits & Inspections] 

• Support continuous medical inspection readiness efforts in collaboration with applicable global inspections management teams, Business Units, and Platform Line representatives. 
• Communicate relevant audit and inspection trends to respective country stakeholders, ensure that applicable actions are taken to address country gaps. 
• Develop and maintain the in-country Regulatory Inspection Site Notification Plan.  
• Coordinate Regulatory Quality Assurance Pfizer Country Organization (PCO) audits and vendor audits (vendor audits if in IMQG remit, depending on scope), including management of audit Corrective & Preventive Actions (CAPAs).  
• Support Corporate Audit requests within scope of IMQG as appropriate. 
• Support external inspections as appropriate in partnership with global inspection management teams. 
• Support maintenance of professional records for Medical Affairs colleagues.

[Issue Escalation and Quality Event Management SOPs & Other Procedures] 

• Drive effective management of quality events (QE) and CAPAs for PCO scoped QEs within MQGM remit and act as the Business Line Quality Group role. 
• Monitor and drive PCO QEs and CAPA performance.  
• Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the medical Quality Management System (QMS). 
• Act as local QMS01 expert and build PCO awareness on issue escalation & remediation requirements in partnership with other quality lines. 
• Develop or support the development, implementation, and maintenance of in-country controlled documents within the scope of QMS04 and within MQGM remit in collaboration with relevant Subject Matter Experts (SME). 
• Ensure local controlled clinical and medical documents within MQGM remit follow applicable Pfizer policies and procedures and regulatory requirements.  
• Facilitate local implementation of global Standard Operating Procedures (SOPs) and ensure relevant communication is cascaded accordingly. 
• Provide input to draft Global SOPs, Policies, Work Instructions (WI) and related training materials offering the country perspective and local impact.

[Training] 

• Ensure local training requirements in MQGM remit are included in the appropriate curricula. 
• Ensure local curricula in MQGM remit are maintained in line with Pfizer standards. 
• Facilitate local training compliance reporting for in-country Medical Affairs where needed.  
• Act as a local Expert on QMS07 and Pfizer’s Global Learning Management System. 
• In collaboration with local management, identify additional training needs on quality related areas (in addition to MEL mandatory requirements); facilitate, support, conduct of additional training for identified areas. 

[Monitoring]  

• Identify local areas for monitoring (e.g. via quality reviews) in collaboration with in-country medical management and IMQG as appropriate.  
• Execute monitoring activities as defined by applicable global quality plans.

[PCO-Specific Responsibilities]  

• Support Business Continuity planning for Medical Management. 
• Manage the filing and archiving of MQG related documents, as appropriate. 

Here Is What You Need (Minimum Requirements) 

• Scientific or technical degree is preferred: BS or MS and over 3 years’ experience in compliance/SOP management, auditing, QA/QC, or related field 
• Experience in Interventional/Non-international studies including PMS is highly preferred.  
• Fluency in English 
• Appreciation of the regulatory compliance issues relating to the local medical function 
• Previous experience in medical affairs activities is valued 
• Supervisory experience in a matrixed organization is valued  
• Excellent technical writing, communication, and presentation skills 
• Proficiency in Microsoft Office, Microsoft Project 
• Experience in preparing and participating in audits and inspections 

Bonus Points If You Have (Preferred Requirements) 

• Expertise in managing multiple complex projects 
• Consultancy skills 
• Ability to work independently 
• Able to lead without reporting line authority at senior level 
• Project Management expertise 
• Excellent verbal, written, and presentation skills 
• Collaboration, interpersonal and facilitation skills 
• Continuous Improvement and/ or organizational effectiveness expertise 
• Display sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization 
• Collaborate efficiently across functional and country boundaries, respecting communication, functional priorities, and cultural differences in interpersonal relationships 
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use 

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Medical Quality Governance Specialist(1-yr contract)