APAC GxP Compliance Lead — Audits & Inspections

ThermoFisher Scientific; Indiana; Hybrid; USD 110,000 - 140,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Compliance Manager to oversee GxP audits and regulatory inspections for the company, investigator sites, and sponsors, primarily supporting the APAC region with additional scope globally. You will lead audit activities, drive CAPAs, mentor staff, and collaborate with diverse teams to ensure quality compliance across programs.

The role requires strong knowledge of GxP and regulatory frameworks, plus experience conducting internal audits and leading

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 5+ years of quality assurance experience in GxP/compliance.
• 1+ year of leadership/management experience preferred.

Responsibilities

• Provide consultation on GxP audit and inspection readiness and follow-up activities.
• Serve as primary client contact for audit/inspection discussions.
• Support client audits and regulatory inspections including risk assessment and CAPA follow-up.
• Lead, review, and approve audit/inspection reports for multiple stakeholders.
• Investigate root causes of findings and drive corrective actions.
• Contribute to lessons learned and company-wide improvement initiatives.
• Develop guidance, policies, and training materials for compliance teams.
• Lead cross-functional process improvements and collaborative projects.
• Mentor junior staff and lead group projects when needed.
• Prepare audit findings for departmental and client meetings.

Skills

GxP knowledge

GCP knowledge

Regulatory knowledge

Internal audits

Root cause analysis

Risk assessment

Communication skills

Presentation skills

Mentoring

Project leadership

MS Office

Veeva QMS

Education

Bachelor's degree

Biology or Pharmacy

Tools

Veeva QMS

Job description

Thermo Fisher Scientific is seeking a Compliance Manager to oversee GxP audits and regulatory inspections for the company, investigator sites, and sponsors, primarily supporting the APAC region with additional scope globally. You will lead audit activities, drive CAPAs, mentor staff, and collaborate with diverse teams to ensure quality compliance across programs.

The role requires strong knowledge of GxP and regulatory frameworks, plus experience conducting internal audits and leading