The role
You will audit our clinical work and our partners' — finding the gaps before an inspector does.
What you will do
- Plan and conduct audits of investigator sites, vendors and internal processes
- Write clear audit reports and track CAPA to genuine closure
- Support inspection readiness and host regulatory inspections
- Advise study teams on GCP interpretation without becoming an obstacle
- Contribute to the quality management system for clinical activities
What success looks like at 12 months
Audits run to schedule, CAPAs close on evidence rather than assertion, and study teams call you before they make a decision rather than after.
What we require
- GCP auditing experience, or deep clinical operations experience ready to move into quality
- Working knowledge of ICH-GCP and applicable regulations
- Ability to write a finding that is accurate, fair and actionable
- Willingness to travel approximately 30%
What we would like, but will teach you
- Regulatory inspection experience
- Vendor and CRO audit experience
- Lead auditor certification
If you meet the required list, apply. We cap the preferred list at four items on purpose, and we would rather read an application from someone who is 70% there and hungry.
Fully remote, open to candidates anywhere in the United States. Occasional travel to a site for team gatherings.
This role is designated portable — it moves with you. If you are a military spouse and receive PCS orders, you keep this job, your grade and your tenure. How that works.
Pay and rewards
This role sits at grade 8, with a base range of $109,000 – $141,000 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
A fully remote role, open to candidates anywhere in the US. More about our locations.
Accommodations
Need an adjustment to apply or interview? Email accommodations@ingenbiotech.example. It goes to a separate team and is never shared with the hiring manager. What we can arrange.
Applications are not enabled on this demonstration site
On a live InGen careers site this button would open a one-page application: a CV and three short questions, about twelve minutes, no account required and no cover letter.