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Manager – Clinical Process And 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: M.Pharm/B.Pharm or M.Sc. Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology

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

Location: Gurgaon / Mumbai, India
Job Type: Full-Time
Experience Required: 10+ Years (Freshers are not eligible)
Industry: Clinical Research / Clinical Quality Assurance / Pharmaceuticals / Drug Development / Life Sciences
Department: Global Development Centre / Clinical Quality & Compliance

About the Role
We are seeking an experienced and strategic Manager – Clinical Process and Quality Manager (CPQM) to lead sponsor oversight, clinical quality governance, and risk-based quality management across global clinical development programs. This senior-level opportunity is ideal for professionals with deep expertise in clinical quality management, ICH-GCP compliance, sponsor oversight, RBQM frameworks, CRO governance, and audit readiness.

The ideal candidate will play a critical leadership role in ensuring quality is proactively embedded across the clinical trial lifecycle, maintaining sponsor accountability, driving inspection readiness, and strengthening global clinical governance frameworks in line with evolving international regulatory standards.

This opportunity is highly suited for senior clinical quality professionals with strong pharmaceutical global development experience.

Key Responsibilities

Sponsor Oversight & Clinical Governance

  • Lead and maintain comprehensive Sponsor Oversight frameworks across global clinical development programs.
  • Ensure effective oversight of CROs, vendors, investigational sites, and external partners based on trial complexity, risk, and critical operational activities.
  • Maintain sponsor accountability for delegated clinical trial activities in accordance with regulatory expectations.
  • Independently assess quality risks, compliance gaps, operational vulnerabilities, and emerging quality signals.
  • Support senior leadership during audits, inspections, and regulatory quality reviews.

Integrated Quality Control (IQC) & Monitoring Oversight

  • Plan, lead, and execute risk-based Integrated Quality Control (IQC) activities across clinical programs.
  • Conduct process reviews, documentation assessments, remote QC reviews, on-site quality visits, and focused evaluations of high-risk activities.
  • Independently verify protocol compliance, data credibility, trial conduct quality, and operational execution.
  • Ensure documentation traceability, inspection readiness, and high-quality governance reporting.

Risk-Based Quality Management (RBQM) Leadership

  • Drive implementation and continuous enhancement of Risk-Based Quality Management (RBQM) frameworks aligned with ICH E6(R3) principles.
  • Support identification of Critical-to-Quality (CtQ) factors impacting subject safety, data integrity, and trial reliability.
  • Develop and maintain study-level risk assessments, quality management plans, and oversight governance strategies.
  • Monitor performance metrics, KRIs, KPIs, centralized monitoring signals, QC findings, and quality trends to proactively manage risks.
  • Ensure preventive quality interventions rather than retrospective issue detection.

Audit, Inspection & CAPA Management

  • Support internal audits, external inspections, health authority reviews, and inspection readiness initiatives.
  • Participate in audit preparation, inspection support, response development, and post-inspection remediation activities.
  • Lead root cause investigations, Corrective and Preventive Action (CAPA) implementation, and sustainable issue resolution.
  • Collaborate with QA and functional teams to address GCP non-compliance, quality events, and scientific integrity concerns.

Quality Reporting, Analytics & Governance Oversight

  • Deliver structured governance reporting on quality risks, oversight performance, IQC outcomes, and RBQM effectiveness.
  • Conduct trend analysis of findings to identify systemic issues, recurring risks, and process improvement opportunities.
  • Present governance insights and mitigation strategies to stakeholders and leadership teams.
  • Ensure quality intelligence supports operational decision-making and continuous compliance improvement.

Quality Systems & Continuous Improvement

  • Support development, review, and implementation of SOPs, QMS frameworks, training programs, controlled documents, and quality governance procedures.
  • Monitor compliance with internal quality systems and identify improvement opportunities across clinical development operations.
  • Evaluate the impact of evolving global regulations on clinical operations, sponsor oversight, and quality management frameworks.
  • Contribute to enterprise quality transformation and process excellence initiatives.

Required Qualifications

  • Advanced degree in Pharmacy, Medicine, Life Sciences, Clinical Research, Biomedical Sciences, or related healthcare disciplines.
  • Master of Pharmacy (M.Pharm) preferred.
  • 10+ years of global clinical research experience, including sponsor oversight, monitoring, clinical quality governance, or quality management leadership.
  • Strong expertise in ICH-GCP, ICH E6(R3), sponsor oversight requirements, RBQM frameworks, audit readiness, and CRO/vendor governance.
  • Proven experience managing quality systems (QMS), inspections, CAPA, trend analysis, and compliance oversight.
  • Strong knowledge of global pharmaceutical clinical development operations and regulatory expectations.
  • Excellent communication, stakeholder management, escalation handling, and leadership capabilities.
  • Willingness to travel up to 30% as required.