Head of Quality Audits & Inspections (On-site, Odense)

Job summary

The Head of Quality Audits & Inspections will lead the Corporate Audit & Inspection team to ensure compliance with regulatory requirements and internal quality standards. This role involves providing strategic guidance on quality and compliance across the organization.

Qualifications

• Leadership experience in Quality Assurance, GxP Compliance, Auditing, or Inspection Management.
• Certified Lead Auditor qualification preferred.
• Extensive knowledge of global regulatory requirements (GMP, GDP, ICH, FDA, etc.).

Responsibilities

• Lead and manage the audit team, providing coaching and performance management.
• Develop and execute an annual risk-based audit program for GxP processes and suppliers.
• Ensure compliance with global regulations and internal procedures.
• Continuously improve audit and inspection management processes.
• Drive inspection readiness activities and support regulatory inspections.
• Review audit reports and manage CAPA for timely closure of observations.
• Monitor audit trends and identify systemic issues.
• Develop compliance KPIs to aid management decision-making.

Skills

• Strong leadership and people management skills.
• Analytical and problem-solving capabilities with a strategic mindset.
• Results-oriented with a focus on continuous improvement.
• Ability to maintain positive stakeholder relationships and lead cross-functional initiatives.

Education

• Relevant degree in a related field is typically expected.

Tools

• Familiarity with audit management software and compliance tracking tools is beneficial.