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Job Purpose
The Clinical Process and Quality Manager (CPQM) is responsible for enabling Sponsor Oversight, Quality Control, and Risk-Based Quality Management (RBQM) across global clinical development activities in alignment with ICH E6(R3).
The role will support all Global Development Organization (GDO) functions and shall ensure that quality is built into trial design and conduct, sponsor accountability is maintained despite delegation, and trials remain inspection-ready throughout their lifecycle.
- Sponsor Oversight & Accountability:
Maintains documented Sponsor Oversight frameworks, ensuring appropriate oversight of CROs, vendors, and investigational sites based on trial complexity, risk, and criticality of activities.
Ensures that delegation of trial activities does not absolve Sponsor accountability, and that oversight mechanisms remain effective throughout the trial lifecycle.
Provides independent assessment and escalation of quality risks, compliance gaps, and emerging signals to appropriate governance bodies.
Supports senior leadership in demonstrating active Sponsor oversight during audits and regulatory inspections
Provides quality oversight of CROs, vendors, and partner organizations, assessing performance against contractual obligations, quality expectations, and regulatory requirements.
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Plans, leads, and conducts risk-based IQC activities, including:
In-house process and documentation risk-based IQC reviews
Remote and on-site QC visits
Focused reviews of high-risk processes, data, vendors, and sites
Ensures QC activities provide independent verification of trial conduct, data credibility, and compliance with protocol, SOPs, and regulatory requirements.
Leads RBQM in accordance with ICH E6(R3), ensuring quality is proactively planned, implemented, monitored, and improved throughout the trial lifecycle.
Supports study teams in identifying Critical-to-Quality (CtQ) factors, including critical data, processes, and endpoints impacting subject safety and data reliability.
Contributes to the development and maintenance of study-level risk assessments, Quality Management Plans, and oversight strategies.
Performs ongoing risk review and signal detection using QC findings, metrics, KPIs, KRIs, centralized monitoring outputs, and trend analysis.
Ensures that quality actions are risk-proportionate, focused on preventing issues rather than detecting errors retrospectively.
- Audit, Inspection & Issue Management:
Supports audit and regulatory inspection readiness, including preparation, participation, response development, and post‑inspection follow-up, as assigned.
Ensures that QC, audit, and inspection findings are adequately investigated, root causes are appropriately identified and CAPAs are effective and sustainable.
Collaborates with QA, GDO functions, and service providers to manage serious GCP non-compliance, quality events, and potential scientific misconduct, including appropriate documentation, escalation, and governance oversight.
- Reporting and Governance:
Provides periodic, structured quality and oversight reports to stakeholders, including IQC outcomes, risk assessments and trends, RBQM effectiveness and key quality risks and mitigation status
Performs trend analysis of all IQC findings to identify systemic issues, recurring risks, including identification of any process gaps and recommends appropriate actions.
Ensures lessons learned are translated into process improvements, training updates, and enhanced oversight models.
Reviews, develops, and supports implementation of SOPs, controlled documents, and training programs relevant to Sponsor Oversight and RBQM.
Monitors adherence to SOPs and report on compliance issues, works with assigned GDO function heads to address any deviations or areas of improvement.
Supports QA in QMS implementation and other quality initiatives, as and when needed.
Evaluates the impact of evolving international and national regulations and guidelines on clinical development operations.
Actively contributes to continuous improvement initiatives within department.
Qualification, Skill and Competencies Requirements
Advanced degree in Medicine/Pharmacy/Life Sciences; Master’s preferred.
10+ years’ global clinical research experience, including sponsor oversight and on-site monitoring of multi‑centric trials.
Strong expertise in ICH‑GCP, global regulations, and sponsor accountabilities.
Proven experience in clinical quality management, including QMS, risk-based quality oversight, trend analysis, and CAPA.
Experience managing audits, inspections, and inspection readiness activities.
Effective oversight of CROs, vendors, and investigators, including management of quality issues and escalations.
Excellent stakeholder engagement, communication, and negotiation skills.
Willingness to travel up to 30%.
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
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