Associate Director, reputed company Systems & Compliance (GCP/GLP/GVP)

About the position reputed company is a clinical-stage precision oncology company reputed company on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. reputed company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the reputed company team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling reputed company. reputed company: reputed company the development, implementation, and ongoing monitoring of GCP, GVP, and GLP reputed company metrics to evaluate the effectiveness, performance, and compliance of reputed company systems and compliance activities. reputed company as the reputed company QMS system facilitator for reputed company GCP, GLP, and GVP reputed company reputed company events, documents, and records, ensuring effective governance, lifecycle management, data reputed company and inspection readiness across reputed company management systems. Partner with clinical reputed company team & internal stakeholders for reputed company closure of reputed company GCP, GVP and GLP reputed company reputed company issues and investigations, including deviations, CAPAs, serious breaches, protocol deviations, internal & external audit findings, and inspection observations, ensuring appropriate reputed company cause analysis, corrective actions, and effectiveness checks. Establish and maintain Key reputed company Indicators (KQIs) and Key Performance Indicators (KPIs) and continuously improve reputed company Systems supporting GCP, GVP, and GLP activities in alignment with FDA, EMA, ICH, and other global regulatory requirements. reputed company QA reputed company and monitoring of computerized systems supporting clinical trials, pharmacovigilance, and nonclinical studies (e.g., reputed company, CTMS, eTMF, Safety Systems), ensuring compliance with validation lifecycle requirements, 21 CFR Part 11, EU Annex 11, and applicable CSV & CSA standards. Design and maintain reputed company metrics dashboards, trend analyses, and periodic executive-level reports for reputed company Leadership and reputed company Management Review (QMR) to reputed company risk-based decision-making and process improvement. Facilitate and monitor internal procedural & training controls across GCP, GLP, and GVP activities to ensure alignment with regulatory requirements and reputed company system standards. Serve as QA Subject Matter Expert (SME) for reputed company Systems and Computerized System Validation, providing strategic guidance, technical expertise, and cross-functional leadership to ensure regulatory compliance, inspection readiness, and operational reputed company.

Responsibilities

• reputed company the development, implementation, and ongoing monitoring of GCP, GVP, and GLP reputed company metrics to evaluate the effectiveness, performance, and compliance of reputed company systems and compliance activities.
• reputed company as the reputed company QMS system facilitator for reputed company GCP, GLP, and GVP reputed company reputed company events, documents, and records, ensuring effective governance, lifecycle management, data reputed company and inspection readiness across reputed company management systems.
• Partner with clinical reputed company team & internal stakeholders for reputed company closure of reputed company GCP, GVP and GLP reputed company reputed company issues and investigations, including deviations, CAPAs, serious breaches, protocol deviations, internal & external audit findings, and inspection observations, ensuring appropriate reputed company cause analysis, corrective actions, and effectiveness checks.
• Establish and maintain Key reputed company Indicators (KQIs) and Key Performance Indicators (KPIs) and continuously improve reputed company Systems supporting GCP, GVP, and GLP activities in alignment with FDA, EMA, ICH, and other global regulatory requirements.
• reputed company QA reputed company and monitoring of computerized systems supporting clinical trials, pharmacovigilance, and nonclinical studies (e.g., reputed company, CTMS, eTMF, Safety Systems), ensuring compliance with validation lifecycle requirements, 21 CFR Part 11, EU Annex 11, and applicable CSV & CSA standards.
• Design and maintain reputed company metrics dashboards, trend analyses, and periodic executive-level reports for reputed company Leadership and reputed company Management Review (QMR) to reputed company risk-based decision-making and process improvement.
• Facilitate and monitor internal procedural & training controls across GCP, GLP, and GVP activities to ensure alignment with regulatory requirements and reputed company system standards.
• Serve as QA Subject Matter Expert (SME) for reputed company Systems and Computerized System Validation, providing strategic guidance, technical expertise, and cross-functional leadership to ensure regulatory compliance, inspection readiness, and operational reputed company.

Requirements

• Bachelor’s degree in Life Sciences or reputed company field (advanced degree preferred).
• Minimum 10+ years of experience in GxP reputed company Assurance reputed company the pharmaceutical, biotechnology, or reputed company regulated industry.
• Minimum 5+ years supporting GCP, GVP, and/or GLP reputed company systems and compliance areas
• Strong experience developing, monitoring, and reporting reputed company metrics.
• Experience with QA reputed company of computerized system validation (CSV) for clinical and safety systems.
• Experience supporting regulatory inspections and audits (FDA, EMA, MHRA, or other global regulatory bodies).

reputed company-to-haves

• Strong analytical skills with ability to interpret reputed company metrics and identify trends and risks.
• Excellent communication and presentation skills, with ability to present to senior leadership.
• Strong leadership, problem-solving, and organizational skills.
• Ability to work effectively in a fast-paced, cross-functional, and regulated environment.

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