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Medical Quality Manager – India

3+ years
Not Disclosed
10 Nov. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Hiring: Medical Quality Manager – India

📍 Location: Mumbai, India
💼 Job Type: Full-time
🆔 Job ID: 4943382
📅 Posted: 6 Days Ago


About Pfizer

Pfizer is committed to breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

Pfizer Global Supply (PGS) drives high-quality product delivery through flexible, compliant, and risk-based quality systems that prioritize patient safety.


Position Overview

The Medical Quality Manager (MQM) ensures medical quality, audit/inspection readiness, and risk mitigation within the in-country Medical Affairs business unit. The role spans local operations under the Global Medical Affairs Quality Oversight Committee and involves cross-functional processes with medical involvement or inspection risk.


Key Responsibilities

Quality Management

  • Lead Level 1 medical quality oversight and business support at the market level.

  • Develop country medical quality strategic initiatives based on risk and business needs in collaboration with local medical management, IMQ, and key stakeholders.

  • Execute Global Quality Plans and maintain Country Operational Plans.

  • Demonstrate MQ value proposition to internal and external stakeholders.

Audits & Inspections

  • Drive continuous medical inspection readiness in collaboration with global inspections management teams and business units.

  • Communicate audit and inspection trends to country stakeholders and ensure corrective actions are implemented.

  • Maintain Regulatory Inspection Site Notification Plans.

  • Coordinate Regulatory QA audits, vendor audits, and manage audit CAPAs.

  • Support corporate audit requests and external inspections as appropriate.

Issue Escalation & Quality Event Management

  • Manage quality events (QE) and CAPAs within the MQM remit.

  • Monitor and drive PCO QEs and CAPA performance.

  • Serve as local QMS01 expert and build awareness of issue escalation and remediation requirements.

SOP & Procedure Management

  • Develop, implement, and maintain in-country controlled documents within QMS04 scope.

  • Act as local expert on QMS04 ensuring clinical and medical documents meet Pfizer policies, procedures, and regulatory requirements.

  • Facilitate local implementation of global SOPs and provide input to global SOPs, policies, and work instructions.

  • Support impact assessment of new or revised regulatory requirements affecting the medical QMS.

Training

  • Ensure local training requirements are included and maintained in Pfizer curricula.

  • Facilitate training compliance reporting and conduct additional training as identified.

  • Serve as local expert on QMS07 and Pfizer’s Global Learning Management System.

Monitoring

  • Identify areas for local monitoring in collaboration with medical management and IMQ.

  • Execute monitoring activities as per applicable global quality plans.


Required Skills & Experience

Education & Experience:

  • Scientific or technical degree (BS or MS preferred)

  • Over 3 years’ experience in compliance, SOP management, auditing, QA/QC, or related field

  • Understanding of local promotional compliance environment

  • Experience in a matrixed organization is valued

Technical & Behavioral Skills:

  • Fluency in English

  • Expertise in managing multiple complex projects

  • Ability to work independently and lead without direct reporting line authority

  • Strong project management skills

  • Excellent verbal, written, and presentation skills

  • Collaboration, interpersonal, and facilitation skills

  • Continuous improvement and organizational effectiveness expertise

  • Ability to build collaborative relationships across functions, countries, and cultures


Work Location

  • Mumbai, India


Equal Opportunity

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


🔗 Apply Now: Pfizer Careers – Medical Quality Manager

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