ROLE SUMMARY
The Medical Quality Governance Manager (MQGM) Algeria, Morocco, Tunisia, and ELI Cluster (Egypt, Sudan, Lebanon, Jordan, Iraq, Iran) reports to the Global Medical Quality Governance (GMQG) MERA Saudi & Turkey Cluster Lead and is accountable for successful execution of local quality related activities and risk mitigation for identified medical processes.
This role delivers medical quality oversight and quality consultation activities locally and is accountable for audit and inspection readiness. The MQGM 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.
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The MQGM works with the GMQG MERA Saudi & Turkey Cluster Lead to drive consistency and enable increased communication and information sharing across Regional GMQG Leadership and PCO colleagues, while promoting a culture of quality locally.
ROLE RESPONSIBILITIES
GMQG Processes, Services and Operating Model
- Deliver medical quality oversight and quality consultation activities locally as per globally driven goals and initiatives.
- Draw upon best practices and identifies innovative ways of working and continuous improvement efforts to strengthen local quality and overall adherence with medical processes to help to ensure a state of control for relevant business processes.
- Participate in local Risk Management Forums, governance boards, and appropriate regional governance structures, as needed
- Drive and oversee effective management of Serious Quality Events/Quality Events (SQE/QE) and Corrective and Preventive Actions (CAPAs) in GMQG scope for assigned markets, as per Pfizer requirements
- Monitor and drive CAPA performance as applicable.
- Act as local QMS01 medical expert and build awareness on issue escalation & remediation requirements.
- Partner with GMQG MERA Saudi & Turkey Cluster Lead and Business Process Owners (BPOs) to drive implementation of policies and procedures in scope of GMQG in assigned markets, and ensure that proper controls and oversight is in place for local country medical documents
AUDIT AND INSPECTION
- Lead continuous inspection readiness efforts in collaboration with applicable headquarters inspections management teams, BUs, and Platform Line representatives as applicable.
- Develop and maintain the in-country Regulatory Inspection Site Notification Plan.
- Communicate relevant Inspection announcements as per applicable Regulatory Inspection Site Notification Plans.
- Coordinate RQA PCO audits, and provide support for audit systems.
- Provide consultancy recommendations for audit-related Corrective & Preventive Actions (CAPAs) as applicable.
- Support Corporate Audit requests within scope of GMQG as appropriate.
SOPs, PROCEDURES AND TRAINING OVERSIGHT
- Support the process of impact assessment of new or revised regulatory requirements and legislation impacting the local clinical and medical controlled documents (CMCDs) local references.
- Develop or support the development, implementation, and maintenance of in-country controlled documents within the scope of QMS04 and within MQGM remit in collaboration with relevant Subject Matter Experts.
- Act as local expert on QMS04 and ensure that local CMCDs within MQGM remit follow applicable Pfizer policies and procedures and regulatory requirements.
- Provide input to draft Global /SOPs /Policies/Working Instructions and related training materials offering the country perspective and local impact
TRAINING
• Ensure local training requirements in MQGM remit are included in the appropriate curricula.
• Ensure local curricula in MQGM remit are maintained in line with Pfizer standards.
• Facilitate local training compliance reporting for in-country Medical Affairs where needed.
• Act as a medical expert on QMS07 and Pfizer's Global Learning Management System.
• In collaboration with local management, identify additional local training needs on quality related areas; facilitate/ support/ conduct of additional training for identified areas if applicable.
MONITORING
• Identify areas for monitoring (quality reviews) in collaboration with in-country medical management teams and GMQG, as appropriate.
• Execute monitoring activities as defined by applicable global quality plans.
BASIC QUALIFICATIONS
- Advanced academic qualifications in science, health, business or technology- related field preferred, with equivalent relevant professional experience
- 5+ years of pharmaceutical industry experience managing multiple and highly complex projects.
- 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
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.
Quality Assurance and Control
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