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.

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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.

/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.

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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 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.

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- Conduct supplier audits and 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.

/n /n Regulatory Compliance & Health Authority Support /n /n

- Interpret and implement global regulatory requirements impacting clinical supply chain operations.

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- Provide expert guidance on FDA, EMA, MHRA, PMDA, Health Canada, and other international regulatory requirements.

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- Support preparation and review 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.





/n /n Quality Systems Leadership /n /n

- 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.

/n /n Audits & Inspection Readiness /n /n

- 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 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.

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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 analytics and 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