Purpose & Scope
The Medical Quality Governance Manager (MQGM) drives medical quality, audit/inspection readiness and risk mitigation for in‑country/cluster medical. The scope covers market areas in the Medical Quality Oversight Committee's purview and cross‑functional processes with medical involvement or inspection risk.
Organizational Relationships
Interacts with market & cluster medical, platform line organisations, and other quality & compliance representatives. Member of relevant country/cluster medical and quality / compliance leadership teams.
* Internal stakeholders: Medical Evidence Development, Global Medical Quality Governance, International Medical Affairs Leadership, 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, Digital.
* External stakeholders: Industry associations, vendors, license/alliance partners.
Main Responsibilities / Duties
* Drive Level 1 medical quality oversight and business support at the market/cluster level.
* Lead development of country and cluster medical quality strategic initiatives through collaboration with local medical management, IMQ and other stakeholders.
* Execute Global & Local Quality Plans and maintain Country Operational Plan initiatives.
* Demonstrate medical quality value proposition to internal stakeholders and external customers.
* Lead continuous inspection readiness, communicate audit/inspection trends, maintain Regulatory Inspection Site Notification Plan.
* Coordinate audits and vendor audits, manage Corrective & Preventive Actions (CAPAs).
* Support Corporate Audit requests within IMQ scope and external inspections partnership.
* Support maintenance of professional records for CMAO Medical colleagues.
* Manage quality events (QEs) and CAPAs for MQGM‑scoped QEs.
* Support process for impact assessment of new regulatory requirements and legislation.
* Act as local QMS01 and QMS04 expert; facilitate local implementation of global SOPs.
* Provide input to draft global SOPs, policies, work instructions and training materials.
* Ensure local training requirements are met, maintain curricula, report training compliance, and facilitate additional training as needed.
* Identify and execute local quality monitoring activities.
Required Skill Set
* Scientific or technical degree preferred (BS/MS) with 3+ years experience in compliance, SOP management, auditing, or related field.
* Understanding of local promotional compliance environment.
* Appreciation of regulatory compliance issues for local medical function.
* Experience in drug development process valued.
* Supervisory experience in matrixed organization considered a plus.
* Knowledge of training design and tools and experience applying training methodology considered a plus.
* Fluency in English.
* Expertise in managing complex projects.
* Consultancy skills.
* Ability to work independently and 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.
* Advisor for managing relationships with sensitivity and building collaborations.
* Collaboration across functional and country boundaries, respecting communication and cultural differences.
Equal Employment Opportunity
We believe diversity and inclusion is crucial to building a successful business. Pfizer is committed to celebrating all forms of diversity and ensuring equal employment opportunities for all candidates. We encourage reasonable adjustments to support disability inclusion. Candidates who can provide official disability certificates will be considered.
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