CQR Expert - Clinical Supply Chain

Capgemini Engineering · India

CQR Expert – Clinical Supply Chain

Location : Mumbai/Bangalore/Coimbatore Compliance & Quality Management

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

Clinical Supply Chain Oversight

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

Supplier Quality & Vendor Governance

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

Regulatory Compliance & Health Authority Support

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

Quality Systems Leadership

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

Audits & Inspection Readiness

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

Risk Management & Continuous Improvement

• Conduct enterprise-level risk assessments for clinical supply chain processes and external partners.
• Identify operational, supplier, quality, and regulatory risks impacting clinical programs.
• Develop mitigation plans and monitor effectiveness of implemented controls.
• Drive continuous improvement initiatives utilizing Lean, Six Sigma, and Quality-by-Design methodologies.
• Leverage data analytics and performance metrics to enhance compliance and operational effectiveness.
• Promote a culture of quality, compliance, integrity, and continuous improvement.