Assoc Dir Clinical QA - Remote
About the position
Responsibilities
• Provides Quality oversight and support of Tolmar Inc. clinical development programs.
• Supports the Tolmar Inc. Clinical Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems in accordance with ICH E6 (Rx).
• Executes on and/or provides oversight of quality monitoring and assurance of clinical trial execution of Tolmar Inc. sponsored protocols.
• Executes on and/or provides oversight of clinical investigator audits, documentation audits and other study-specific or process audits.
• Engages with study teams and functions for proactive inspection readiness across all clinical programs.
• Conducts external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities.
• Communicates audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes.
• Tracks, reviews, approves, and assesses the efficiency of CAPAs.
Requirements
• Experience in clinical quality assurance and compliance with GCP principles.
• Knowledge of FDA, EMA, Health Canada, and ICH regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
Nice-to-haves
• Experience with clinical trial management systems (CTMS).
• Familiarity with electronic data capture (EDC) systems.
Benefits
• Health insurance coverage.
• 401k retirement savings plan.
• Paid holidays and vacation days.
Apply Now
Apply Now
Responsibilities
• Provides Quality oversight and support of Tolmar Inc. clinical development programs.
• Supports the Tolmar Inc. Clinical Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems in accordance with ICH E6 (Rx).
• Executes on and/or provides oversight of quality monitoring and assurance of clinical trial execution of Tolmar Inc. sponsored protocols.
• Executes on and/or provides oversight of clinical investigator audits, documentation audits and other study-specific or process audits.
• Engages with study teams and functions for proactive inspection readiness across all clinical programs.
• Conducts external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities.
• Communicates audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes.
• Tracks, reviews, approves, and assesses the efficiency of CAPAs.
Requirements
• Experience in clinical quality assurance and compliance with GCP principles.
• Knowledge of FDA, EMA, Health Canada, and ICH regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
Nice-to-haves
• Experience with clinical trial management systems (CTMS).
• Familiarity with electronic data capture (EDC) systems.
Benefits
• Health insurance coverage.
• 401k retirement savings plan.
• Paid holidays and vacation days.
Apply Now
Apply Now