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Manager – Clinical Process And Quality Manager (Cpqm)

Sun Pharma
Sun Pharma
8-15 years
preferred by company
Gurgaon, Mumbai, India
1 May 14, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Manager – Clinical Process and Quality Manager (CPQM)
Location: Gurgaon, Haryana, India / Mumbai, Maharashtra, India
Employment Type: Full-Time
Department: Global Development Centre / Clinical Quality / Clinical Operations Excellence
Experience Required: 8–15+ Years (Significant Clinical Quality & GCP Experience Preferred)

 


Job Overview

A strategic leadership opportunity is available for an experienced Manager – Clinical Process and Quality Manager (CPQM) within the global clinical development quality domain. This role is ideal for professionals with deep expertise in clinical quality management, sponsor oversight, risk-based quality management (RBQM), GCP compliance, clinical audits, vendor oversight, and inspection readiness.

The selected candidate will play a critical role in strengthening quality governance across global clinical development programs by ensuring robust sponsor oversight, integrated quality control, and proactive risk-based quality management aligned with ICH E6(R3) expectations.

This role is highly suited for professionals seeking advancement in clinical quality assurance, sponsor oversight leadership, GCP compliance, clinical governance, and pharmaceutical quality strategy.


Key Responsibilities

Sponsor Oversight & Clinical Governance

  • Establish and maintain robust sponsor oversight frameworks across global clinical programs
  • Ensure sponsor accountability remains effective despite delegation of trial responsibilities
  • Oversee CROs, vendors, investigational sites, and external partners based on trial complexity and operational risk
  • Conduct independent assessments of quality risks, compliance gaps, and emerging operational concerns
  • Support senior leadership during audits and regulatory inspections by demonstrating effective sponsor governance

Risk-Based Quality Management (RBQM)

  • Lead implementation of Risk-Based Quality Management (RBQM) aligned with ICH E6(R3) standards
  • Support study teams in identifying Critical-to-Quality (CtQ) factors impacting patient safety and data integrity
  • Contribute to development of:
    • Study-level risk assessments
    • Quality Management Plans (QMPs)
    • Oversight frameworks
    • Risk mitigation strategies
  • Perform ongoing risk reviews using:
    • Quality metrics
    • KPIs
    • KRIs
    • Trend analysis
    • Centralized monitoring outputs
    • Quality findings data
  • Ensure quality interventions remain proactive and prevention-focused

Integrated Quality Control (IQC)
Lead risk-based quality control activities including:

  • In-house documentation reviews
  • Process quality assessments
  • Remote QC reviews
  • On-site QC visits
  • Focused reviews of:
    • High-risk processes
    • Clinical data
    • Vendor performance
    • Site operations

Ensure quality control activities validate:

  • Trial conduct quality
  • Protocol compliance
  • Data credibility
  • SOP adherence
  • Regulatory compliance
  • Inspection readiness documentation

Audit, Inspection & CAPA Management

  • Support audit readiness and regulatory inspection preparation
  • Participate in inspections, response planning, and post-inspection follow-up activities
  • Lead investigation of:
    • QC findings
    • Audit observations
    • Inspection issues
    • Compliance deviations
  • Drive:
    • Root Cause Analysis (RCA)
    • CAPA development
    • CAPA implementation
    • Effectiveness monitoring
  • Support management of serious GCP non-compliance and quality events

Vendor & CRO Quality Oversight

  • Assess CRO and vendor performance against:
    • Contractual obligations
    • Quality standards
    • Regulatory expectations
    • Operational performance metrics
  • Strengthen third-party oversight models and sponsor governance mechanisms

Reporting & Quality Governance

  • Prepare structured quality governance reports covering:
    • IQC outcomes
    • RBQM effectiveness
    • Risk trends
    • Quality findings
    • Compliance posture
    • Mitigation action status
  • Present insights to internal stakeholders and leadership
  • Identify recurring systemic issues and recommend governance improvements

Quality Systems & Continuous Improvement

  • Review and support implementation of:
    • SOPs
    • Controlled quality documents
    • Training programs
    • Compliance processes
  • Support Quality Management System (QMS) initiatives
  • Evaluate impact of evolving regulatory requirements on clinical operations
  • Drive continuous improvement initiatives across development quality functions

Required Qualifications

Educational Qualifications
Candidates should hold a Bachelor’s or advanced degree in:

  • Life Sciences
  • Pharmacy
  • Biotechnology
  • Clinical Research
  • Medicine
  • Nursing
  • Related healthcare or scientific disciplines

Advanced qualifications are preferred.