Job Description CQR Expert – Clinical Supply Chain
n Location : Mumbai/Bangalore/Coimbatore Compliance & Quality Management
n n Ensure clinical supply chain processes comply with GxP, GMP, GDP, GCP, ICH guidelines, and global regulatory requirements.
n Develop, review, approve, and maintain Quality Management System (QMS) documentation, including SOPs, work instructions, quality agreements, and compliance records.
n Establish quality governance frameworks and compliance strategies for clinical supply operations.
n Monitor quality and compliance metrics, identify trends, potential risks, and systemic gaps.
n Lead deviation investigations, change controls, CAPAs, root cause analyses, and effectiveness assessments.
n Maintain inspection readiness and ensure continuous compliance across clinical supply chain functions.
n Drive implementation and optimization of electronic Quality Management Systems (eQMS) and digital quality initiatives.
n n Clinical Supply Chain Oversight
n n Provide strategic quality oversight for clinical supply planning, forecasting, manufacturing, packaging, labeling, storage, distribution, returns, reconciliation, and destruction activities.
n Ensure compliance of Investigational Medicinal Product (IMP) lifecycle management across global clinical trials.
n Review and approve clinical supply chain documentation, procedures, protocols, and quality records.
n Ensure product traceability, chain-of-custody, chain-of-identity, and serialization requirements are maintained where applicable.
n Oversee temperature-controlled logistics and cold-chain operations supporting global study requirements.
n Support supply continuity planning and risk mitigation strategies to avoid disruptions to clinical studies.




n Collaborate with supply planning and operational teams to ensure compliant and uninterrupted product supply.
n n Supplier Quality & Vendor Governance
n n Lead qualification, onboarding, periodic assessment, and risk-based oversight of CMOs, CROs, depots, warehouses, distributors, and transportation providers.
n Conduct supplier audits and quality assessments to evaluate compliance with regulatory and internal quality requirements.
n Establish supplier quality metrics, scorecards, and performance monitoring programs.
n Review and approve supplier quality agreements and compliance documentation.
n Lead remediation activities and CAPA follow-up for supplier quality issues and audit observations.
n Partner with Procurement and Vendor Management teams to strengthen supplier governance processes.
n n Regulatory Compliance & Health Authority Support
n n Interpret and implement global regulatory requirements impacting clinical supply chain operations.
n Provide expert guidance on FDA, EMA, MHRA, PMDA, Health Canada, and other international regulatory requirements.
n Support preparation and review of regulatory submissions involving clinical supply manufacturing, packaging, labeling, storage, and distribution.
n Assess emerging regulatory trends and communicate potential impacts to business stakeholders.
n Serve as a key quality representative during regulatory inspections and health authority interactions.
n Lead responses to regulatory observations, inspection findings, and compliance commitments.




n n Quality Systems Leadership
n n Own and oversee quality events impacting clinical supply operations.
n Lead management of deviations, investigations, CAPAs, risk assessments, and change controls.
n Implement Quality Risk Management (QRM) methodologies in accordance with ICH Q9 principles.
n Conduct trend analysis on quality events, audit findings, and compliance metrics.
n Ensure effectiveness and sustainability of corrective and preventive actions.
n Drive continuous enhancement of quality systems and compliance processes.
n n Audits & Inspection Readiness
n n Lead internal audits, supplier audits, mock inspections, and external regulatory inspections.
n Develop and maintain inspection readiness plans and compliance monitoring programs.
n Coordinate audit preparation activities and readiness assessments across functional teams.
n Present audit outcomes, compliance risks, and remediation plans to leadership.
n Track audit observations and ensure timely closure of corrective actions.
n Support customer audits and inspections conducted by regulatory authorities.
n n Risk Management & Continuous Improvement
n n Conduct enterprise-level risk assessments for clinical supply chain processes and external partners.
n Identify operational, supplier, quality, and regulatory risks impacting clinical programs.
n Develop mitigation plans and monitor effectiveness of implemented controls.
n Drive continuous improvement initiatives utilizing Lean, Six Sigma, and Quality-by-Design methodologies.
n Leverage data analytics and performance metrics to enhance compliance and operational effectiveness.
n Promote a culture of quality, compliance, integrity, and continuous improvement.
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📌 CQR Expert - Clinical Supply Chain (Bengaluru)
🏢 Capgemini Engineering
📍 Bengaluru