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We are seeking an experienced member to join our Quality Assurance team. The Compliance Auditor plays a pivotal role in ensuring that clinical research laboratory testing operations comply with global regulatory standards and industry-recognized best practices, including GCP/GLP, ISO 15189, and ISO 13485. This position leads the internal audit program execution, drives process improvements, collaborates with management to implement audit strategies, mentors’ junior auditors, and collaborates with cross-functional teams to uphold quality and regulatory integrity across clinical laboratory testing and operational environments. The ideal candidate will possess strong leadership skills, a keen eye for detail, and the ability to oversee complex audit functions in a fast-paced environment with minimal direction. This role requires proactive, timely and responsive engagement with stakeholders, ensuring compliance with industry regulations and internal standards while continuously improving auditing processes.
Job Responsibility
Managing the Internal Audit Program: Plan and implement the internal audit program
Schedule and oversee the approved audit program
Develop and clarify audit scopes to ensure comprehensive assessments
Approve and assign internal audits to appropriate team members
Preparedness and Oversight: Ensure appropriate stakeholder engagement throughout the audit process
Facilitate effective planning and communication with all relevant parties
Audit Hosting & Regulatory Support: Serve as the primary host for internal audits
Provide regulatory inspection support and host sponsor audits as required
Severity Finding and Audit Report Review with Management: Document audit findings and develop detailed reports with actionable recommendations
Collaborate with stakeholders to implement CAPAs and monitor their effectiveness
Lead audit review meetings and collaborate with management to address compliance gaps
Audit Program Monitoring: Lead and manage monthly audit meetings
Monitor audit activities, ensuring alignment with regulatory requirements
Ensure audit and regulatory inspection readiness, in harmony with CLS QA programs and global processes
Internal Auditor Development: Provide training and mentorship for internal auditors
Collaborate with QA management and Regulatory Intelligence to ensure regulatory updates are proceduralized, and embraced through staff training and team huddles
Develop audit leads and ensure continuous professional development and compliance awareness
Quality Assurance (QA) Support: Support, lead and participate in QA projects as needed to uphold compliance standards and continuous improvement strategic initiatives
Requirements
Bachelor's degree in a Pharmacy, Chemistry or Biology related discipline
Postgraduate degree (MSG or equivalent) in science or management related discipline, preferable
10 years’ experience may be substituted for education
8 years in regulatory environment (experience in GLP/GCP roles)
4 years Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards
Strong written and verbal communication skills
Excellent organizational and project management abilities
Strong negotiation, influencing and networking skills
Demonstrative skills include risk management application experience including risk-based auditing methodologies
Experience in training and developing internal auditors
Experience with quality management system and regulatory compliance inspections
Experience leading process improvement initiatives
Experience with compliance software such as Veeva or Trackwise
Nice to have
8 years - Regulatory expertise - detailed knowledge of specific regulation/ multiple regulations
2 years’ experience as Lead Auditor with strategic communication with clients