Pfizer Medical Quality & Oversight Manager in Ho Chi Minh, Vietnam
The Medical Quality & Oversight Manager (MQOM) role drives quality management, compliance, inspection readiness, training, process improvements, and oversight needed to ensure high quality performance of Pfizer Country Medical Operations
The MQCM scope spans the local areas that are defined by the Medical Quality Management System (QMS), where these impact in-country Medical Operations. This may include lines beyond Medical, e.g., Commercial, where these are involved in regulated activities governed by the Medical QMS.Quality Management
Drive the local Country Quality Management System
Lead the development of country quality & compliance strategic initiatives based on risk and business needs, in close collaboration with Local Medical Management, MQC Leadership, and other key stakeholders (e.g., Commercials and Platform Line management [Safety, Regulatory]
Develop and maintenance Country Quality Plan
Quality consulting activities (e.g., answer to queries on medical compliance requirements, CEPs, Promotional Compliance....)
Proactively identify quality risk in scope of Quality Management System and work for strategy to mitigate the risk.
Promote Pfizer policies and global Standard Operation Process to apply for relevant activities in the country.
Audits & Inspections
Lead continuous inspection readiness efforts in collaboration with applicable headquarters inspections management teams, Business Line, and Platform Line representatives.
Communicate relevant Inspection / audit trends to respective country stakeholders, drive that applicable actions are taken to address country gaps
Develop and maintain the in-country Regulatory Inspection Action Plan. Lead, coordinate or support local regulatory authority inspections as per Pfizer standards, depending on inspection scope
Coordinate internal audits within the scope of in-country Medical Operations, including management of audit Corrective & Preventive Actions (CAPAs). Support external inspections as appropriate
Support maintenance of professional records for Medical colleagues
SOPs & Other Procedures
Drive the local impact assessment of new and revised local regulatory requirements and ensure these are appropriately documented in in-country controlled documents within MQO remit
Develop (and/or support the development), implement and maintain in-country controlled documents for the area under the scope of MQCM
Facilitate local implementation of global SOPs and ensure relevant communication is cascaded accordingly
Quality Issues Management and Escalation
Upon identification of risk or potential quality issue, escalate to management as per Pfizer standards
Drive effective management of quality issues and Corrective & Preventive Actions (CAPAs).
Ensure training requirements related to Medical and Compliance processes are included in the appropriate curricula
Act as a local Subject Matter Expert on local training management and Pfizer's Global Learning Management System
Ensure country colleagues have sound knowledge of regulatory requirements: in collaboration with local Management, identify additional training needs; facilitate / support / conduct of additional training for identified areas.
Identify areas & conduct for quality reviews in collaboration with in-country Medical Management and Platform Lines, and Regional Medical Quality & Oversight, as appropriate
Define and implement improvement strategies, based on quality analytics
To be assigned as needed
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.