Auditing Manager – Regulatory Compliance (Biotech)

About the Role:  

We are seeking a highly skilled and detail-oriented Auditing Manager with deep understanding of regulatory compliance to join our quality team in a growing biotech organization. The ideal candidate will lead and manage internal and external audits, ensure compliance with global regulatory standards (such as FDA, EMA, ICH, ISO), and drive a culture of continuous quality improvement. This role is critical in maintaining the integrity of our operations and ensuring we meet both industry and legal expectations.

Key Responsibilities:  

• Plan, execute, and lead internal audits across departments to assess compliance with GMP, GLP, GCP, and other regulatory standards.
• Manage external audits (regulatory agencies, partners, and vendors), including audit readiness, hosting, and CAPA development.
• Evaluate company policies, SOPs, and documentation to ensure compliance with evolving regulatory guidelines.
• Collaborate with cross-functional teams (R&D, manufacturing, clinical, QA/RA) to prepare for inspections and implement audit findings.
• Conduct risk assessments and maintain audit schedules, reports, and corrective/preventive action plans (CAPAs).
• Monitor and track regulatory changes and proactively update internal stakeholders and processes.
• Train internal teams on audit readiness, compliance standards, and regulatory best practices.
• Contribute to continuous improvement initiatives and drive a quality-focused culture within the organization.

Required Qualifications:  

• Bachelor’s or Master’s degree in Life Sciences, Quality, Regulatory Affairs, or a related field.
• 5+ years of auditing or quality compliance experience in the biotech, pharmaceutical, or medical device industry.
• Strong knowledge of FDA, EMA, ICH, ISO 13485, and other global regulatory frameworks.
• Demonstrated experience leading audits (internal, supplier, or regulatory).
• Excellent report-writing and documentation skills.
• Proficient in use of QMS tools and audit management systems.

Preferred Qualifications:  

• Professional certifications such as CQA, RAC, or ISO Lead Auditor.
• Experience working in GxP environments (GMP, GLP, GCP).
• Familiarity with electronic quality systems and audit tracking tools.
• Experience with CAPA systems and root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagram).
• Strong interpersonal skills with the ability to influence cross-functional teams.