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AfME Cluster MQO Lead, Sr. Mngr


Dubai, Dubai
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Job Details

**PURPOSE** The Cluster Medical Quality Oversight Manager (Cluster MQOM) role drives efforts and activities needed to enable and sustain Quality and Inspection Readiness across different Business Units (PEH, PIH) where specified within scope of Pfizer's Medical R&D Quality Management System (QMS), for the countries under the Cluster MQO Lead's responsibility and the Regional Medical Teams

**SCOPE** **Geographic area** **:**

AFME i.e. Africa Middle East Region (Algeria, Tunisia, Morocco, West Africa, NEAR, Gulf & Levant, Egypt, South Africa, Saudi Arabia, AFME Regional Office)

**Business** **Unit:**

Reports into PIH, also supports PEH


+ Reports to the MQO Lead AFME & LA-Can

+ Functional oversight (dotted line) over MQOMs/MQOLs in the cluster

**MAIN REPONSIBILITIES / DUTIES** **Quality Management**

+ Drive the Medical Quality program and strategies and overall culture of Quality within the region, in partnership with MQO Lead AFME/LA-Can, other Cluster MQOMs, Regional Medical Management, Country Medical Directors and other relevant stakeholders.

+ Lead MQO risk assessment activities for the region and provide strategic input for the Global MQO Strategic and Quality Plans.

+ Oversee the development and maintenance of the Country Quality Plans within the cluster.

+ Design and implement MQO risk mitigation strategies for the region in collaboration with relevant stakeholders.

+ Monitor and drive quality performance for the region in partnership with the MQO Lead AFME/LA-Can and other cluster MQOMs.

+ Provide quality consultancy to colleagues in scope, demonstrating knowledge and understanding of the individual markets.

**Audits and Inspections**

+ In collaboration with MQO Lead AFME/LA-Can and Country Medical Directors, oversee all aspects of PCO Medical Inspection Readiness, including Communication, Documentation, Training, Quality and Inspection Readiness Plan, Process and Risk Controls.

+ Ensure MQOMs within the cluster know their role on audit/inspections and are able to fulfill it by offering materials and training opportunities.

+ Monitor cluster and country audit/inspection outcomes, share learnings, flag areas of concern to MQO Lead AFME/LA-Can/Country Medical Directors.

+ Understand Audit/Inspection trends and ensure timely action from MQOMs in the cluster.

+ Enable compliance to Inspection Readiness, Professional Records and Training standards by promoting the use of the professional record repositories and contributing to PCO medical training curricula maintenance.

+ Provide support for regional/country audits and inspections as needed.

**CAPA Management and Execution**

+ Drive and oversee effective management of quality events (QEs) and Corrective and Preventive Actions (CAPAs) for the region, as per Pfizer requirements.

+ Continuously monitor QE and CAPA performance within the region.

+ Upon identification of risk or potential quality events, escalate as per Pfizer standards.

+ Act as QE Reviewer for the QEs within the region and fulfill the QMS01 SME role:

+ Act as technical expert on QMS01 and provide guidance to MQOMs when necessary.

+ Represent MQO in different BPO/SME meetings/forums and have strong interaction with the global BPO/SMEs.

+ Conduct/ coordinate teleconferences and training sessions for MQOMs, communicate/cascade relevant communications to MQOMs, in partnership with other Cluster MQOMs, MQO management, global BPO, SMEs.

**S** **OPs and Other Procedures**

+ Partner with the MQO Lead AFME/LA-Can to drive implementation of policies and procedures in scope of MQO in the cluster.

+ Secure that proper control and oversight are in place to ensure compliance of country Medical controlled documents.


+ Support the MQO Lead AFME/LA-Can to ensure consistent training and communication plans for the region.

+ Facilitate regional/country training compliance.

**People Management**

+ Provide functional oversight of MQOMs in the cluster.

+ In collaboration with MQO Lead AFME/LA-Can support Country Medical Director (CMDs) with MQOM talent management in the cluster.

+ Facilitate mentoring, coaching, training and development of MQOMs, in collaboration with Country Medical Directors.

+ Recruit MQOMs for strategic projects, monitor project completion.

+ Provide input to MQOMs performance review and developmental plans

**Regional Medical Teams MQOM**

+ Act as Regional Medical Teams MQOM with focus on the following but not limited to areas: internal stakeholder mapping, regional medical projects, quality reviews, professional records, training compliance, quality consultancy, promotional materials, medical interactions, CEP/CITs, significant quality events, general inspection readiness.

+ Member of the AFME medical LT and act as interface between medical leadership and the regional MQO organization

+ Promote culture of quality across Regional/Country Business Units and Platform Lines where appropriate.


+ Lead and/or support global/regional quality-related projects.

+ Act as deputy for MQO Lead AFME/LA-Can and/or back-up for Cluster MQOMs within the region

+ Interact with internal and external networks.

+ Demonstrate value proposition of MQO to internal and external stakeholders.

+ Ensure appropriate information and communication management within the cluster.

**REQUIRED SKILLS** **Education & Experience**

+ Scientific or technical degree is preferred: BS or MS and preferably over 5-7 years' experience in quality/SOP management, auditing, QA/QC or related field

+ Supervisory experience in a matrixed organization is valued

+ Prior experience in a country operation is valued

+ Experience in managing multiple complex projects is valued

**Technical/Functional Competencies:**

+ Excellent command of both written and spoken English.

+ Experience and proven capabilities in quality and/or audit matters

+ Experience in navigating a large, complex matrix organization and managing stakeholders' interests.

+ Strong project management skills.

+ Experience in developing and executing training at all levels of the organization.

+ Excellent analytical skills with a demonstrated ability in risk identification, measurement and assessment, risk monitoring, reporting and escalation.

+ Ability to work in a fast-paced and demanding environment.

+ Strong organization and planning skills.

+ Ability to communicate well within all levels of Pfizer with high level of influence and impact skills

+ Senior management engagement and communication skills

+ Availability for travel as required (up to 25%, seasonal)

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