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Manager – Clinical Process & Quality Manager (Cpqm)

Sun Pharma
Sun Pharma
10+ years
preferred by company
Gurgaon, Mumbai, India
2 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Pat, Clinical SAS Programming, Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien

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

Company: Sun Pharma
Location: Gurugram / Mumbai, India
Business Unit: Global Development Centre
Employment Type: Full-Time
Industry: Clinical Quality Assurance / Clinical Operations / Global Clinical Development / GCP Compliance

Job Overview

Sun Pharma is hiring a Manager – Clinical Process & Quality Manager (CPQM) to lead Sponsor Oversight, Integrated Quality Control (IQC), Risk-Based Quality Management (RBQM), inspection readiness, and clinical quality governance across global clinical development programs.

This leadership role is ideal for professionals with strong expertise in ICH-GCP, sponsor oversight, CRO/vendor quality management, audit readiness, CAPA management, and clinical trial quality systems.

The position ensures quality is embedded throughout the clinical trial lifecycle while maintaining sponsor accountability across outsourced and internal development activities.


Key Responsibilities

Sponsor Oversight & Accountability

Lead sponsor oversight frameworks across global studies.

Responsibilities include:

  • Oversight of CROs
  • Vendor quality governance
  • Investigational site oversight
  • Sponsor accountability maintenance
  • Risk-based oversight execution

Ensure:

  • Delegated activities remain under sponsor accountability
  • Effective oversight mechanisms are documented
  • Trial governance remains inspection-ready

Provide leadership support during:

  • Regulatory inspections
  • Sponsor audits
  • Governance reviews

CRO & Vendor Quality Oversight

Manage quality oversight for:

  • CRO partners
  • External vendors
  • Clinical service providers
  • Partner organizations

Responsibilities:

  • Performance monitoring
  • Contractual quality oversight
  • Compliance assessments
  • Quality issue escalation
  • Vendor risk management

Ensure service providers meet:

  • Regulatory requirements
  • Quality expectations
  • Study commitments

Integrated Quality Control (IQC)

Plan and execute risk-based IQC activities.

Key activities:

  • Process quality reviews
  • Documentation QC reviews
  • Remote QC assessments
  • On-site QC visits
  • High-risk data/process reviews
  • Site-focused quality checks

Ensure:

  • Independent verification of trial conduct
  • Protocol compliance
  • Data credibility
  • Inspection traceability

Risk-Based Quality Management (RBQM)

Lead RBQM implementation aligned with ICH E6(R3).

Responsibilities:

  • Quality planning
  • Risk identification
  • Monitoring quality risks
  • Signal detection
  • Preventive quality strategy

Support study teams with:

  • Critical-to-Quality (CtQ) factor identification
  • Risk assessment frameworks
  • Quality Management Plans
  • Oversight strategy design

Use data from:

  • KPIs
  • KRIs
  • Centralized monitoring
  • QC trends
  • Quality metrics

Clinical Risk Management

Proactively identify and escalate:

  • Quality risks
  • Compliance gaps
  • Operational signals
  • Emerging study issues

Ensure:

  • Timely mitigation
  • Risk-proportionate action
  • Governance escalation
  • Preventive intervention

Audit & Inspection Readiness

Lead inspection preparedness across programs.

Responsibilities:

  • Audit preparation
  • Regulatory inspection support
  • Inspection participation
  • Response development
  • Follow-up remediation

Support readiness for:

  • GCP inspections
  • Internal audits
  • Sponsor audits
  • Regulatory authority reviews

CAPA & Issue Management

Lead investigation and remediation activities.

Responsibilities:

  • Root cause analysis
  • CAPA development
  • CAPA effectiveness verification
  • Sustainable corrective action implementation

Manage:

  • Serious GCP non-compliance
  • Quality events
  • Scientific misconduct concerns
  • Escalation workflows

Quality Reporting & Governance

Prepare structured quality governance reporting.

Reports may include:

  • IQC outcomes
  • Risk trends
  • RBQM effectiveness
  • Quality signal summaries
  • Mitigation progress
  • Oversight health indicators

Support governance decision-making through actionable reporting.


Trend Analysis & Continuous Monitoring

Analyze recurring issues and systemic risks.

Responsibilities:

  • Trend analysis
  • KPI review
  • Quality pattern identification
  • Process gap analysis
  • Preventive recommendations

Convert findings into:

  • Process improvements
  • Oversight enhancements
  • Better quality frameworks

SOPs, QMS & Process Excellence

Support clinical quality systems development.

Responsibilities:

  • SOP review
  • Controlled document development
  • Training support
  • Compliance monitoring
  • QMS initiatives
  • Quality framework implementation

Partner with QA and development teams to strengthen operational quality systems.


Regulatory Intelligence

Monitor evolving:

  • Global regulations
  • Clinical guidelines
  • GCP updates
  • National regulatory expectations

Evaluate operational impact and support implementation.


Required Qualifications

Education

Advanced degree in:

  • Medicine
  • Pharmacy
  • Life Sciences

Preferred: Master’s degree


Experience Required

10+ years of global clinical research experience

Must include:

  • Sponsor oversight
  • Clinical monitoring
  • Multi-center clinical trials
  • Clinical quality management
  • CRO/vendor oversight