Senior GCP Quality & Compliance Auditor

Position Overview

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.

Key Responsibilities

• Lead and execute comprehensive quality and compliance audits (including internal, vendor, and site audits) 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 for both internal and external stakeholders.
• Coordinate and conduct clinical site audits in collaboration with project management teams, ensuring efficient audit execution.
• Lead audit facilitation with external auditors and regulatory authorities and ensure thorough preparation and representation.
• Analyze audit findings and direct the preparation of detailed reports, identifying risks, gaps, and improvement areas.
• Oversee and review corrective action/preventative action (CAPA) plans to ensure timely and effective resolution of non-compliance issues.
• Perform trend analysis on audit findings to support continuous quality improvement initiatives.
• Develop and lead the auditor training program for Corporate Quality, ISO auditors, and other staff, focusing on audit techniques, risk assessment, and systematic approaches.
• Organize and conduct mock inspections to prepare teams for external regulatory audits and identify potential compliance risks.
• Review and approve audit reports prepared by junior auditors, ensuring accuracy, clarity, and regulatory alignment.
• Stay current with evolving regulations and best practices related to clinical research activities to maintain effective audit strategies.
• Ensure all employees complete training on time and maintain a minimum level of 90% training compliance at all times.

Required Qualifications

• Education: Honor's Bachelor (minimum)
• Experience: 7-9 years in a quality auditing function within a CRO, pharmaceutical, biotechnology, or related organization
• Strong understanding of compliance and risk management issues related to clinical research, including research ethics and privacy principles
• Previous experience leading a team is required

Preferred Qualifications

• Certified Auditor (ASQ, ISO, or equivalent)
• Expertise in regulations and standards governing clinical research including ICH GCP, ISO 19011, and EMA guidelines on computerized systems and data integrity in clinical trials
• Advanced technical knowledge in global regulations and industry standards as they apply to clinical research, medical devices, and pharmaceuticals
• Familiarity with medical imaging and clinical research industry regulations and standards
• Experience working in and collaborating with a cross-functional global team environment
• Excellent verbal and written communication skills for drafting documents, reports, and presentations
• Strong interpersonal skills, including effective listening, facilitating group discussions, and providing appropriate feedback
• Ability to plan, organize, prioritize, and manage workload independently
• Adaptability to changing environments with a quick learning curve
• Superior analytical skills focused on identifying potential compliance issues, investigating root causes, and assessing the effectiveness of corrective actions
• Proven ability to interpret and synthesize data to identify risks, trends, and aggregated issues

Benefits & Perks

• + bonus
• Remote Work: Home-based, Remote, regular office-hours

Important Notice

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