GCP Manager (Quality & Compliance)

Responsibilities

• GCP Compliance Oversight
• Ensure all clinical trials are conducted in compliance with ICH-GCP, regulatory requirements, and sponsor SOPs.
• Provide GCP oversight across Phase I–IV clinical trials conducted globally.
• Interpret and implement GCP regulations, guidance documents, and industry best practices.
• Monitor adherence to protocol, regulatory commitments, and ethical standards.
• Quality Management & Risk Oversight
• Develop and implement Quality Management Systems (QMS) related to clinical research.
• Support implementation of Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) strategies.
• Review Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and risk logs.
• Identify systemic quality risks and recommend corrective actions.
• Audit & Inspection Readiness
• Plan, coordinate, or support GCP audits including:
• Investigator site audits
• Vendor audits
• Internal process audits
• Support preparation for regulatory inspections (FDA, EMA, MHRA, etc.).
• Manage inspection readiness activities, documentation review, and mock inspections.
• CAPA Management
• Oversee Corrective and Preventive Action (CAPA) processes related to GCP findings.
• Investigate protocol deviations, compliance issues, and audit findings.
• Track CAPA implementation and effectiveness.
• Ensure timely closure of audit observations.
• Clinical Trial Oversight
• Provide independent quality oversight of CROs, vendors, and investigative sites.
• Review key trial documents including:
• Protocols
• Monitoring plans
• Data management plans
• Safety reporting procedures
• Ensure appropriate sponsor oversight of outsourced activities.
• SOP Development and Maintenance
• Develop, review, and maintain clinical SOPs, work instructions, and quality procedures.
• Ensure procedures align with:
• ICH E6(R2)/E6(R3)
• Regulatory requirements
• Company quality systems.
• Training and GCP Education
• Develop and deliver GCP training programs for clinical teams.
• Ensure training compliance across clinical staff and vendors.
• Provide guidance on GCP interpretation and best practices.
• TMF and Documentation Compliance
• Ensure compliance with Trial Master File (TMF) requirements.
• Conduct TMF health checks and quality reviews.
• Ensure essential documents are complete, accurate, and inspection ready.
• Vendor and CRO Oversight
• Evaluate CRO and vendor quality systems.
• Participate in vendor qualification and oversight activities.
• Review vendor performance and compliance metrics.
• Regulatory & Ethical Compliance
• Ensure compliance with:
• Institutional Review Boards (IRB)/Ethics Committees
• Regulatory submissions and approvals
• Safety reporting requirements (SAE/SUSAR).
• Continuous Improvement
• Identify opportunities to improve clinical processes and quality systems.
• Implement lessons learned and best practices across programs.
• Support quality culture across clinical teams.

Qualifications

• Bachelor's or Advanced degree in life sciences, pharmacy, or medicine.
• 5+ years of experience in quality and clinical development in pharma space with involvement in regulated clinical trials, clinical safety, pharmacovigilance.
• Strong knowledge of ICH-GCP, FDA, EMA regulations.
• Experience with audits, inspections, and quality systems.
• Prior experience with CRO oversight and global trials.