* The Medical Quality Governance Manager (MQGM) drives medical quality, audit/inspection readiness and risk mitigation for in-country/cluster medical.* 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.* 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).* 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.* External stakeholders include – Industry associations, vendors, license/alliance partners.* Drive Level 1 medical quality oversight and business support at the market/cluster level, aligning with platform lines, as appropriate.* 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]).* Execute Global & Local Quality Plans.* Develop, maintain and execute Country Operational Plan initiatives, as applicable.* Demonstrate medical quality value proposition to internal stakeholders and where appropriate, external customers.* 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.* Monitor and drive PCO QEs and CAPA performance and improvement efforts.* Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the medical Quality Management System (QMS).* Act as local QMS01 expert and build PCO awareness on issue escalation & remediation requirements in partnership with other quality lines.* 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).* 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.* Facilitate local implementation of global Standard Operating Procedures (SOPs) and ensure relevant communication is cascaded accordingly.* Provide input to draft Global SOPs, Policies, Work Instructions (WI) and related training materials offering the country perspective and local impact.* 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 country/cluster Medical, where needed.* Act as a local Expert on QMS07 and Pfizer's Global Learning Management System.* 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.* Scientific or technical degree is preferred: BS or MS and over 3 years' experience in compliance/SOP management, auditing, or related field.* Understanding of the local promotional compliance environment.* Appreciation of the regulatory compliance issues relating to the local medical function.* Previous experience in a role involved in the drug development process is valued.* Supervisory experience in a matrixed organization is valued* Knowledge of training design and tools and experience in applying training methodology is considered a plus* Fluency in English* Expertise in managing multiple complex projects* Consultancy skills* Ability to work independently* Able to lead without reporting line authority at senior level* Project Management expertise* Excellent verbal, written, and presentation skills* Collaboration, interpersonal and facilitation skills* Continuous Improvement and/ or organizational effectiveness expertise* Display sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization* Collaborate efficiently across functional and country boundaries, respecting communication, functional priorities, and cultural differences in interpersonal relationships#J-18808-Ljbffr