Senior GCP Quality & Compliance Auditor

Job Description

Job Description

As a technical expert in quality and compliance, the Senior Quality & Compliance Auditor plays a critical role in ensuring adherence to company policies, study protocols, GxP guidelines, and global regulatory requirements governing clinical research activities. This position requires a deep understanding of regulatory frameworks and risk-based auditing methodologies to drive compliance, enhance quality standards, and mitigate organizational risks.

Audit Planning, Execution, and Management Responsibilities

• Lead and execute comprehensive quality and compliance audits in accordance with regulations and standards governing clinical research (including internal audit, vendor audit and site audit) to assess adherence to regulatory standards and company policies
• Develop and implement strategic, risk-based audit plans to proactively identify areas of concern and ensure regulatory compliance
• Provide expert consultation on GxP requirements and quality assurance strategies, guiding both internal and external stakeholders
• Coordinate and conduct clinical sites audit in collaboration with project management teams, ensuring efficient and effective audit execution
• Lead audit facilitation efforts with external auditors and regulatory authorities, ensuring thorough preparation and representation of Alimentiv
• Analyze and interpret audit findings to author or direct the preparation of detailed audit reports, identifying risks, gaps, and areas for improvement
• Oversee and review corrective action / preventative action (CAPA) plans, ensuring timely implementation and effectiveness in addressing non-compliance issues
• Perform trend analysis on audit findings, providing data-driven insights to support continuous quality improvement initiatives
• Develop and lead Alimentiv’s auditor training program for Corporate Quality, ISO auditors and other Alimentiv staff by providing guidance on audit techniques, risk assessment and system approach
• Organize and conduct mock inspections to prepare teams for external regulatory audits and identify potential compliance risks before formal inspections
• Review and approve audit reports prepared by junior auditors, ensuring accuracy, clarity, and regulatory alignment
• Stay abreast of evolving regulations and best practices related to clinical research activities to ensure the company's audit strategies remain current and effective.
• All employees are expected to complete training on time and maintain a minimum level of 90% training compliance at all times.

QUALIFICATIONS

Requirements :

Strongly Preferred :

Interpersonal Skills :

Work location and conditions : Home-based, Remote, regular office-hours

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