Medical Quality Governance Associate – Saudi Arabia & Gulf

ROLE SUMMARY

The Medical Quality Governance Associate (MQGA) Saudi Arabia and the Gulf will work with the Medical Quality Governance Manager (MQGM) Saudi Arabia & Gulf and reports to the Global Medical Quality Governance (GMQG) MERA, Saudi & Turkey Cluster Team Lead and is accountable for successful execution of local quality related activities and risk mitigation for identified medical processes for Medical in Worldwide Medical & Safety (WMS) and Business Unit (BU) Medical Affairs.   

As an active member of the GMQG Regional GMQG EM-China group, as well as a liaison with the Pfizer Country Office (PCO) Medical leadership team, the MQGA will continuously support the MQGM to implement strategic medical quality initiatives within assigned market(s).  The MQGA is accountable for supporting the MQGM in implementing aspects of the GMQG framework and operating model aligned with the Medical Affairs Quality Oversight Committee (MA QOC) and supports the execution, tracking, and remediation of quality plans and communicates the results to country medical leadership for all assigned countries. 

This role delivers medical quality execution and oversight activities locally and is accountable for audit and inspection readiness. The MQGA draws upon best practices and identifies innovative ways of working and uses continuous improvement efforts to continually strengthen local quality and overall adherence with medical processes to help ensure a state of control for relevant business processes.    

The MQGA works with the MQGM & GMQG MERA Saudi & Turkey Cluster Team Lead to drive consistency and enable increased communication and information sharing across Regional GMQG Leadership, Medical Excellence, and PCO colleagues, while promoting a culture of quality locally.

ROLE RESPONSIBILITIES

QUALITY MANAGEMENT

• In conjunction with the MQGM to drive:
  • Local Country Quality Management System.
  • Development of country quality strategic initiatives based on risk and business needs, in close collaboration with Local Medical Management, MQG Leadership, BU Markets and other key stakeholders (e.g., Platform Line management [Safety, Regulatory].
  • Development and maintenance of Country Quality Plan.
• Demonstrate value proposition of MQG to internal stakeholders and external customers.
• Quality consulting activities (e.g., answer to queries on medical quality requirements).
• Ensure appropriate connections to internal stakeholders across lines.

AUDIT AND INSPECTION

• Coordinate continuous inspection readiness efforts in conjunction with MQGM and applicable headquarters inspections management teams, Business Units, and Platform Line representatives.
• In conjunction with MQGM to ensure that applicable actions are taken to address country gaps.
• Maintain the in-country the Site Notification Plan.
• 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 MQG remit.
• 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 MQGM.
• Ensure local controlled documents within MQG remit are following applicable Pfizer policies and procedures and regulatory requirements.

QUALITY ISSUES MANAGEMENT & ESCALATION

• Upon identification of risk or potential quality issue, escalate to management as per Pfizer standards.
• Drive effective management of quality issues and CAPAs.

TRAINING

• Ensure training requirements are included in the appropriate curricula.
• Ensure local curricula are maintained in line with Pfizer standards,
• Ensure country colleagues have sound knowledge of regulatory requirements: in collaboration with local Management, identify additional training needs (in addition to PLA mandatory requirements); facilitate / support / conduct of additional training for identified areas.

QUALITY REVIEWS

• Identify areas for quality reviews in collaboration with MQGM, in-country Medical Management and Platform Lines, and Regional MQG, 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.

BASIC QUALIFICATIONS

• Basic academic qualifications in science, health & pharmacy with equivalent relevant professional experience
• 3-5 years of experience in the fields of Internal Audit, Assurance, Risk Management, Quality Standards, Compliance, Safety, Medical Affairs, including experience with highly matrixed teams
• Knowledge of relevant Medical Affairs processes, compliance, regulatory requirements and other global/local evolving legislation
• Experience creating and executing quality plans and risk mitigation strategies for medical activities
• Excellent organizational, analytical, strategic, interpersonal, written and oral skills
• Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.

PREFERRED QUALIFICATIONS

• Demonstrated strength in influencing and negotiation skills and ability to communicate effectively and build relationships at all levels of the organization
• Ability to maintain a calm demeanor through challenging and complex situations
• Demonstrated success in developing/redesigning processes and measuring effectiveness and efficiency

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Periodic travel to other Pfizer locations may be required, teleconferences outside of normal working hours

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