Cqr expert - clinical supply chain

<p> CQR Expert – Clinical Supply Chain </p> <p> Location : Mumbai/Bangalore/Coimbatore Compliance &amp; Quality Management Ensure clinical supply chain processes comply with Gx P, 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 (e QMS) and digital quality initiatives. </p><p> 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. </p><p> Supplier Quality &amp; 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. </p><p> Regulatory Compliance &amp; 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. </p><p> 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. </p><p> Audits &amp; 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. </p><p> Risk Management &amp; 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. </p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p>