GCP Manager (Quality & Compliance)

GCP Manager (Quality & Compliance) Pennington, NJ Job Details Full-time 1 day ago Qualifications Quality control corrective actions Regulatory inspections Medicine Document review (document control) Procedural guides Audit engagement planning 5 years Compliance audits & assessments Corrective and preventive actions (CAPA) Quality assurance audits ICH guidelines Clinical staff training Clinical research compliance Continuous improvement Staff training Quality improvement Pharmacy Good Clinical Practice Regulatory submissions Research regulatory compliance Training & development IRB compliance Senior level Vendor risk management FDA regulations

Full Job Description Description:

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. (For outsourced projects) 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.

Requirements:

QUALIFICATIONS - SKILLS & REQUIREMENTS

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, pharmcovigilance. Strong knowledge of

ICH-GCP, FDA, EMA

regulations. Experience with audits, inspections, and quality systems. Prior experience with CRO oversight and global trials.

EDUCATION & EXPERIENCE

Advanced degree in life sciences, pharmacy, or medicine.

TRAVEL:

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