Cualquier información adicional que necesite para este trabajo se encuentra en el texto a continuación. Asegúrese de leerla detenidamente y luego envíe su solicitud.
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The Medical Quality Governance Manager (MQGM) drives medical quality, audit/inspection readiness and risk mitigation for in-country/cluster medical.
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The MQGM scope spans market areas that are in scope of the Medical Quality Oversight Committee and Cross-Functional Processes with a Medical involvement or inspection risk, based on the agreement with the Business Process Owner, International Medical Quality (IMQ) and/or country/cluster needs.
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The MQGM is expected to interact closely with market & cluster Medical, platform line organizations, other quality and compliance representatives (e.g., Commercial Quality, Supply Chain/Product Quality, Compliance) and is a member of any relevant country/cluster medical and quality/compliance leadership teams or communities (e.g.
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Country Medical Council).
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Internal stakeholders include, but are not limited to; all teams within Medical Evidence Development, Global Medical Quality Governance, International Medical Affairs Leadership & associated functions, Supply Operations Quality, Clinical Development & Operations, Regulatory Quality Assurance, Corporate Compliance, Legal, Corporate Audit, Global Product Development, Commercial Quality, Safety, Regulatory Sciences, General Privacy Office and Digital.
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External stakeholders include – Industry associations, vendors, license/alliance partners.
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Drive Level 1 medical quality oversight and business support at the market/cluster level, aligning with platform lines, as appropriate.
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Lead the development of country & contribute to cluster medical quality strategic initiatives based on risk and business needs, in close collaboration with local medical management, IMQ, and other key stakeholders (e.g., platform line management [Safety, Regulatory]).
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Execute Global & Local Quality Plans.
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Develop, maintain and execute Country Operational Plan initiatives, as applicable.
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Demonstrate medical quality value proposition to internal stakeholders and where appropriate, external customers.
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Drive effectivemanagement of quality events (QE) and CAPAs for PCO scoped QEs within MQGM to remit and act as the Business Line Quality Group role.
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Monitor and drive PCO QEs and CAPA performance and improvement efforts.
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Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the medical Quality Management System (QMS).
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Act as local QMS01 expert and build PCO awareness on issue escalation & remediation requirements in partnership with other quality lines.
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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 (SME).
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Act as local expert on QMS04 and ensure local controlled clinical and medical documents within MQGM remit follow applicable Pfizer policies and procedures and regulatory requirements.
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Facilitate local implementation of global Standard Operating Procedures (SOPs) and ensure relevant communication is cascaded accordingly.
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Provide input to draft Global SOPs, Policies, Work Instructions (WI) and related training materials offering the country perspective and local impact.
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Ensure local training requirements in MQGM remit are included in the appropriate curricula.
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Ensure local curricula in MQGM remit are maintained in line with Pfizer standards.
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Facilitate local training compliance reporting for country/cluster Medical, where needed.
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Act as a local Expert on QMS07 and Pfizer’s Global Learning Management System.
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In collaboration with local & cluster management, identify additional training needs on quality related areas (in addition to MEL mandatory requirements); facilitate, support, and conduct additional training for identified areas.
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Scientific or technical degree is preferred: BS or MS and over 3 years’ experience in compliance/SOP management, auditing, or related field.
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Understanding of the local promotional compliance environment.
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Appreciation of the regulatory compliance issues relating to the local medical function. xugodme
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Previous experience in a role involved in the drug development process is valued.
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Supervisory experience in a matrixed organization is valued
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Knowledge of training design and tools and experience in applying training methodology is considered a plus
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Fluency in English
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Expertise in managing multiple complex projects
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Consultancy skills