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Medical Quality & Oversight Manager


Wausau, WI 54401
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Job Details

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.

Quality Reviews

+ 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

PCO-Specific Responsibilities

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.
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