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