Pfizer Medical Quality and Oversight Lead/Beijing / in Beijing, China

Quality Management

  • Drive the local Country Quality Management System

  • Lead the development of country quality strategic initiatives based on risk and business needs, in close collaboration with Local Medical Management, MQO Leadership, BU Markets and other key stakeholders (e.g., Platform Line management [Safety, Regulatory])

  • Contribute to regional and global quality strategic initiatives in partnership with Global MQO leadership

  • Development and maintenance of Country Quality Plan

  • Participation in Country Medical Council

  • Demonstrate value proposition of MQO to internal stakeholders and external customers.

  • Quality consulting activities (e.g., answer to queries on medical quality requirements, CEPs, Promotional Compliance)

  • Ensure appropriate connections to internal stakeholders across lines

  • Participate in appropriate regional governance structures (e.g. Promotional Materials Steering Group)

Audits & Inspections

  • Lead continuous inspection readiness efforts in collaboration with applicable headquarters inspections management teams, Business Units, 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

  • Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the Medical Quality Management system

  • Develop (and/or support the development), implement and maintain in-country controlled documents within the scope of QMS04 in collaboration with relevant Subject Matter Experts, meeting the business needs for the area under the scope of Country MQO Lead

  • Ensure local controlled documents within MQO remit are in compliance with applicable Pfizer policies and procedures and regulatory requirements.

  • Facilitate local implementation of global SOPs and ensure relevant communication is cascaded accordingly

  • Provide input to draft Global /SOPs /Policies/Working Instructions and related training materials offering the country perspective and local impact

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 CAPAs. Act as the Business Line Quality Group role for PCO scoped SQEs, within MQO remit.

Training

  • Ensure training requirements are included in the appropriate curricula

  • Ensure local curricula are maintained in line with Pfizer standards

  • Facilitate local training compliance reporting to in-country Medical Management

  • 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 (in addition to P2L mandatory requirements); facilitate / support / conduct of additional training for identified areas.

  • Support training compliance reporting for regional colleagues

Quality Reviews

  • Identify areas for quality reviews in collaboration with in-country Medical Management and Platform Lines, and Regional Medical Quality Oversight, as appropriate

  • Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate

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