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Medical Quality Manager – India

3+ years
Not Disclosed
10 Nov. 13, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Job Title:

Medical Quality Manager (MQM)

Location:

India

Job Type:

Full-Time

Department:

Quality Assurance and Control / Medical Affairs


Purpose & Scope:

The Medical Quality Manager (MQM) is responsible for driving medical quality, audit and inspection readiness, and risk mitigation across the in-country Medical Affairs Business Unit (BU).
The role ensures alignment with the Global Medical Affairs Quality Oversight Committee (GMAQOC) and manages cross-functional processes with medical involvement or inspection risk, in collaboration with International Medical Quality (IMQ) and local business partners.


Organizational Relationships:

The MQM will:

  • Work closely with in-country Medical Affairs, Platform Line organizations, and other quality and compliance representatives (e.g., Commercial Quality, Supply Chain/Product Quality, Compliance).

  • Be a member of relevant country medical and quality/compliance leadership teams or communities such as the Country Medical Council.


Key Responsibilities:

1. Quality Management

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

  • Lead development and execution of country medical quality strategic initiatives in collaboration with local and global stakeholders.

  • Implement Global Quality Plans and develop Country Operational Plans based on business risk and need.

  • Demonstrate the value proposition of Medical Quality within the organization and to external customers.

2. Audits & Inspections

  • Lead continuous medical inspection readiness initiatives in partnership with global inspection teams and business units.

  • Monitor audit and inspection trends, communicate findings, and ensure corrective actions are implemented.

  • Develop and maintain the Regulatory Inspection Site Notification Plan.

  • Coordinate Regulatory QA Pfizer Country Organization (PCO) audits and vendor audits, including management of Corrective & Preventive Actions (CAPAs).

  • Support corporate audits and external inspections in collaboration with global teams.

  • Oversee maintenance of professional records for Medical Affairs colleagues.

3. Issue Escalation & Quality Event Management

  • Manage Quality Events (QEs) and CAPAs within MQM remit and act as Business Line Quality Group lead.

  • Track performance of PCO QEs and CAPAs.

  • Act as a local expert on QMS01, promoting issue escalation and remediation awareness across PCO teams.

4. SOPs & Procedure Management

  • Develop, implement, and maintain in-country controlled documents within QMS04 scope, collaborating with Subject Matter Experts (SMEs).

  • Ensure alignment of local controlled clinical and medical documents with Pfizer global policies, SOPs, and regulatory standards.

  • Support global SOP development by providing country-specific feedback and impact assessments.

  • Manage local implementation and communication of updated global SOPs.

  • Support assessment of new or revised regulatory requirements impacting the Medical Quality Management System (QMS).

5. Training

  • Ensure training curricula and compliance within MQM remit are aligned with Pfizer standards.

  • Act as local expert on QMS07 and Pfizer’s Global Learning Management System (GLMS).

  • Identify and support additional training needs beyond mandatory MEL requirements.

  • Conduct or facilitate quality-related training sessions for Medical Affairs teams.

6. Monitoring

  • Identify local areas requiring monitoring and quality review in collaboration with medical management and IMQ.

  • Execute monitoring activities as per Global Quality Plans.


Required Skill Set

Education & Experience

  • Scientific or technical degree preferred (BS/MS)

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

  • Strong understanding of local promotional compliance environment and medical function compliance issues.

  • Experience working in a matrixed organization is highly valued.

Technical & Behavioral Competencies

  • Fluency in English (written and spoken).

  • Strong project management and organizational skills.

  • Proven ability to manage multiple complex projects independently.

  • Skilled at leading without formal authority at senior levels.

  • Excellent communication, presentation, and interpersonal skills.

  • Demonstrated collaboration and facilitation across functions and geographies.

  • Strong continuous improvement and organizational effectiveness mindset.

  • Culturally sensitive, able to work effectively across boundaries and with diverse teams.


Work Location Assignment:

Hybrid

Job Category:

Quality Assurance and Control / Medical Affairs