GMP Auditor - Remote & Travel-Ready Inspections

Ergomed; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Ergomed is seeking experienced GMP auditors to plan, conduct, report, and follow up on audits for pharmaceutical and biotech clients. The role involves leading internal and external GMP audits for diverse stakeholders and coordinating inspection readiness activities at sponsor and investigator sites.

You will apply deep knowledge of GMP regs, balance timelines with quality, and travel up to 40% while also conducting remote audits as needed.

Qualifications

• Planning, preparation, conduct, reporting and follow up of GMP audits.
• Experience leading internal and external GMP audits for multiple stakeholders.
• Ability to coordinate inspection prep for GMP process inspections at sponsor/investigator sites.
• Extensive knowledge of national and international GMP standards.
• Up to 40% travel and ability to conduct remote audits.

Responsibilities

• Lead GMP audit engagements and ensure timely deliverables.
• Coordinate audit activities with clients and sites to meet regulatory expectations.
• Provide pragmatic solutions to compliance issues.

Skills

GMP audits

Regulatory understanding

Project management

Issue identification

Remote audits

Education

BS in Life Science

Job description

Ergomed is seeking experienced GMP auditors to plan, conduct, report, and follow up on audits for pharmaceutical and biotech clients. The role involves leading internal and external GMP audits for diverse stakeholders and coordinating inspection readiness activities at sponsor and investigator sites.

You will apply deep knowledge of GMP regs, balance timelines with quality, and travel up to 40% while also conducting remote audits as needed.