Pfizer Dir, Med. Quality & Compliance in Beijing, China

PURPOSE

  • The Country Medical Quality Oversight Lead (Country MQO Lead) role drives quality management, compliance, inspection readiness, training, process improvements, and oversight needed to ensure high quality performance of Pfizer Country Medical Operations.

SCOPE

  • The Country MQO Lead 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.

Geographic area covered by the role: China

Business Units: IMB/ EMB

INTERACTIONS / ORGANIZATIONAL RELATIONSHIPS

  • The Country MQO Lead reports solid line into the and dotted line to the Regional MQO Lead through the Cluster MQO Lead, Asia

  • The Country MQO Lead is expected to interact closely with the in-country Business Unit Medical Organizations, the Platform Line organizations and the Quality representatives in Corporate Compliance on all relevant aspects of quality management, Global/Regional stakeholders (e.g. Global SOP teams, BU Medical Quality Oversight Leads).

MAIN REPONSIBILITIES / DUTIES 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

PCO Specific Responsibilities

  • . Please ensure that these do not contradict what is currently in the core section of the job description. Please mention any such PCO specific requirements here e.g. Divisional Corporate Compliance Champion if applicable

REQUIRED SKILLS Education & Experience

  • Medical, Scientific or technical degree is preferred: MD, BS or MS and over 3 years' experience in compliance/SOP management, auditing, QA/QC or related field

  • Understanding of the local promotional compliance environment

  • Appreciation of the regulatory compliance issues relating to the local medical function

  • Previous experience in a role involved in the drug development process is valued

  • Supervisory experience in a matrixed organization is valued

  • Knowledge of training design and tools and experience in applying training methodology is considered a plus

Desired technical and behavioral skills:

  • Fluency in English, Mandarin

  • Expertise in managing multiple complex projects

  • Consultancy skills

  • Ability to work independently

  • Able to lead withou 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

  • Displays sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization;

  • Collaborates efficiently across functional and country boundaries, respecting communication, functional priorities and cultural differences in interpersonal relationships

N: Not Applicable - 不适用 (China)

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