Job DescriptionCQR Expert – Clinical Supply Chain

NLocation: Mumbai/Bangalore/Coimbatore Compliance & Quality Management

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- Ensure clinical supply chain processes comply with GxP, GMP, GDP, GCP, ICH guidelines, and global regulatory requirements.
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- Develop, review, approve, and maintain Quality Management System (QMS) documentation, including SOPs, work instructions, quality agreements, and compliance records.
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- Establish quality governance frameworks and compliance strategies for clinical supply operations.
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- Monitor quality and compliance metrics, identify trends, potential risks, and systemic gaps.
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- Lead deviation investigations, change controls, CAPAs, root cause analyses, and effectiveness assessments.
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- Maintain inspection readiness and ensure continuous compliance across clinical supply chain functions.
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- Drive implementation and optimization of electronic Quality Management Systems (eQMS) and digital quality initiatives.
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nClinical Supply Chain Oversight

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- Provide strategicquality oversight for clinical supply planning, forecasting, manufacturing, packaging, labeling, storage, distribution, returns, reconciliation, and destruction activities.
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- Ensure compliance of Investigational Medicinal Product (IMP) lifecycle management across global clinical trials.
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- Review and approve clinical supply chain documentation, procedures, protocols, and quality records.
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- Ensure product traceability, chain-of-custody, chain-of-identity, and serialization requirements are maintained where applicable.
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- Oversee temperature-controlled logistics and cold-chain operations supporting global study requirements.
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- Support supply continuity planning and risk mitigation strategies to avoid disruptions to clinical studies.
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- Collaborate with supplyplanning and operational teams to ensure compliant and uninterrupted product supply.
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nSupplier Quality &Vendor; Governance

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- Lead qualification, onboarding, periodic assessment, and risk-based oversight of CMOs, CROs, depots, warehouses, distributors, and transportation providers.
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- Conduct supplier auditsand quality assessments to evaluate compliance with regulatory and internal quality requirements.
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- Establish supplier quality metrics, scorecards, and performance monitoring programs.
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- Review and approve supplier quality agreements and compliance documentation.
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- Lead remediation activities and CAPA follow-up for supplier quality issues and audit observations.
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- Partner with Procurement and Vendor Management teams to strengthen supplier governance processes.
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nRegulatory Compliance & Health Authority Support

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- Interpret and implement global regulatory requirements impacting clinical supply chain operations.
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- Provide expert guidanceon FDA, EMA, MHRA, PMDA, Health Canada, and other international regulatory requirements.
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- Support preparation andreview of regulatory submissions involving clinical supply manufacturing, packaging, labeling, storage, and distribution.
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- Assess emerging regulatory trends and communicate potential impacts to business stakeholders.
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- Serve as a key quality representative during regulatory inspections and health authority interactions.
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- Lead responses to regulatory observations, inspection findings, and compliance commitments.
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nQuality Systems Leadership

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- Own and oversee quality events impacting clinical supply operations.
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- Lead management of deviations, investigations, CAPAs, risk assessments, and change controls.
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- Implement Quality Risk Management (QRM) methodologies in accordance with ICH Q9 principles.
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- Conduct trend analysis on quality events, audit findings, and compliance metrics.
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- Ensure effectiveness and sustainability of corrective and preventive actions.
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- Drive continuous enhancement of quality systems and compliance processes.
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nAudits & Inspection Readiness

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- Lead internal audits, supplier audits, mock inspections, and external regulatory inspections.
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- Develop and maintain inspection readiness plans and compliance monitoring programs.
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- Coordinate audit preparation activities and readiness assessments across functional teams.
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- Present audit outcomes,compliance risks, and remediation plans to leadership.
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- Track audit observations and ensure timely closure of corrective actions.
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- Support customer auditsand inspections conducted by regulatory authorities.
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nRisk Management & Continuous Improvement

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- Conduct enterprise-level risk assessments for clinical supply chain processes and external partners.
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- Identify operational, supplier, quality, and regulatory risks impacting clinical programs.
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- Develop mitigation plans and monitor effectiveness of implemented controls.
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- Drive continuous improvement initiatives utilizing Lean, Six Sigma, and Quality-by-Design methodologies.
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- Leverage data analyticsand performance metrics to enhance compliance and operational effectiveness.
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- Promote a culture of quality, compliance, integrity, and continuous improvement.
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📌 Cqr Expert - Clinical Supply Chain (Bengaluru)
🏢 Capgemini Engineering
📍 Bengaluru