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Manager – Clinical Process & Quality Manager (Cpqm)

Sun Pharma
Sun Pharma
10+ years
preferred by company
Gurgaon, Mumbai, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager – Clinical Process & Quality Manager (CPQM)

Company: Sun Pharma
Location: Gurgaon / Mumbai, India
Business Unit: Global Development Centre
Employment Type: Full-Time
Industry: Clinical Quality / Clinical Operations / Global Clinical Development / Pharmaceutical Research

Job Overview

We are hiring a Clinical Process & Quality Manager (CPQM) to lead sponsor oversight, clinical quality governance, risk-based quality management (RBQM), audit readiness, CRO/vendor oversight, and inspection preparedness across global clinical development programs.

This role is ideal for professionals with expertise in clinical quality management, ICH-GCP compliance, sponsor oversight, RBQM, CAPA management, audit/inspection readiness, and global clinical trial governance.

The ideal candidate will ensure quality is embedded throughout the clinical trial lifecycle while maintaining regulatory compliance and sponsor accountability.


Key Responsibilities

Sponsor Oversight & Accountability

Lead and maintain sponsor oversight frameworks for global clinical trials.

Responsibilities include:

  • Oversight of CROs
  • Vendor governance
  • Investigator/site oversight
  • Sponsor accountability monitoring
  • Trial governance support

Ensure delegated activities remain under effective sponsor supervision.

Key focus:

  • Oversight documentation
  • Performance governance
  • Compliance assurance
  • Escalation management

CRO & Vendor Quality Oversight

Provide independent quality oversight for:

  • CRO partners
  • External vendors
  • Investigational sites
  • Service providers
  • Strategic development partners

Evaluate:

  • Contract compliance
  • Quality expectations
  • Operational delivery
  • Regulatory adherence
  • Performance risks

Integrated Quality Control (IQC)

Plan and execute risk-based Integrated Quality Control activities, including:

Quality Review Activities

  • In-house documentation reviews
  • Process quality reviews
  • Risk-focused QC assessments
  • Remote QC reviews
  • On-site QC visits
  • Focused process investigations

Assess:

  • Protocol compliance
  • Data integrity
  • Trial execution quality
  • Documentation completeness
  • Inspection readiness

Risk-Based Quality Management (RBQM)

Lead RBQM implementation aligned with ICH E6(R3).

Core responsibilities:

  • Quality risk planning
  • Risk monitoring
  • Continuous quality review
  • Preventive quality oversight
  • Signal detection

Support development of:

  • Quality Management Plans
  • Risk assessments
  • Oversight strategies
  • Risk mitigation frameworks

Critical-to-Quality (CtQ) Risk Management

Work with study teams to identify and manage:

  • Critical data
  • Critical endpoints
  • Critical processes
  • Patient safety risks
  • Data reliability risks

Ensure proactive quality governance.


Quality Metrics & Signal Detection

Monitor and analyze:

  • KPIs
  • KRIs
  • Quality metrics
  • Centralized monitoring outputs
  • Trend signals
  • QC findings

Identify:

  • Emerging risks
  • Recurring issues
  • Systemic process gaps
  • Compliance concerns

Drive preventive action.


Audit & Inspection Readiness

Lead inspection preparedness activities for clinical programs.

Responsibilities include:

  • Audit preparation
  • Inspection readiness reviews
  • Regulatory inspection support
  • Response coordination
  • Follow-up management

Support:

  • Internal audits
  • Regulatory inspections
  • Sponsor inspections
  • Vendor audits

CAPA & Issue Management

Manage quality events through structured issue resolution.

Responsibilities:

  • Root cause analysis
  • CAPA development
  • CAPA tracking
  • Effectiveness verification
  • Quality issue escalation

Handle:

  • GCP non-compliance
  • Quality deviations
  • Vendor quality failures
  • Inspection observations
  • Scientific misconduct concerns

Governance & Reporting

Develop structured quality governance reporting.

Deliver insights on:

  • Oversight effectiveness
  • Risk status
  • IQC findings
  • CAPA progress
  • Trend analysis
  • Compliance gaps
  • Mitigation status

Provide quality intelligence to leadership.


Quality Systems & SOP Management

Support clinical quality systems including:

  • SOP development
  • Controlled documentation
  • Compliance monitoring
  • Training frameworks
  • QMS implementation

Ensure quality governance processes remain current and effective.


Regulatory Intelligence & Continuous Improvement

Evaluate evolving:

  • Global clinical regulations
  • ICH guidance
  • National regulatory requirements
  • Sponsor oversight expectations

Drive:

  • Process optimization
  • Quality transformation
  • Training improvements
  • Governance enhancements

Required Qualifications

Education

Advanced degree in:

  • Life Sciences
  • Pharmacy
  • Medicine
  • Clinical Research

Master’s preferred


Experience Required

10+ years of global clinical research experience

Required expertise in:

  • Sponsor oversight
  • Clinical monitoring
  • Multi-center clinical trials
  • Clinical quality governance