Assoc Dir Clinical QA - Remote
Posted 2025-08-15
Remote, USA
Full Time
Immediate Start
About the position
The Associate Director of Clinical Quality Assurance (QA) is responsible for ensuring compliance with Good Clinical Practice (GCP) principles and relevant regulations in clinical development programs at Tolmar Inc. This role involves overseeing quality assurance processes, conducting audits, and ensuring inspection readiness across clinical programs.
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 tot his job
The Associate Director of Clinical Quality Assurance (QA) is responsible for ensuring compliance with Good Clinical Practice (GCP) principles and relevant regulations in clinical development programs at Tolmar Inc. This role involves overseeing quality assurance processes, conducting audits, and ensuring inspection readiness across clinical programs.
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 tot his job