Se valorarán las candidaturas que puedan aportar certificados oficiales de discapacidad.
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Envíe su solicitud a continuación después de leer todos los detalles y la información de apoyo sobre esta ocasión de trabajo.
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Las únicas localizaciones disponibles para nuevos empleados serán Madrid, y Barcelona de forma excepcional para algunas funciones específicas.
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Medical Quality Governance Manager (MQGM)
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PURPOSE & SCOPE
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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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ORGANIZATIONAL RELATIONSHIPS
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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. 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, Global Privacy Office and Digital.
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- External stakeholders include – Industry associations, vendors, license/alliance partners.
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MAIN RESPONSIBILITIES / DUTIES
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Quality Management
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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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Audits & Inspections
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- Lead continuous medical inspection readiness efforts in collaboration with applicable global inspections management teams and platform line representatives.
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- Communicate relevant audit and inspection trends to respective country/cluster stakeholders, ensure that applicable actions are taken to address country/cluster gaps.
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- Develop and maintain the in-country Regulatory Inspection Site Notification Plan.
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- Coordinate Regulatory Quality Assurance Pfizer Country Organization (PCO) audits and vendor audits (in accordance with IMQ remit), including management of audit Corrective & Preventive Actions (CAPAs).
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- Support Corporate Audit requests within the scope of IMQ, as appropriate.
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- Support external inspections as appropriate in partnership with global inspection management teams.
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- Support maintenance of professional records for CMAO Medical colleagues.
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Issue Escalation and Quality Event Management
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- Drive effective management 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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SOPs & Other Procedures
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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 lo