The role
You will keep the site ready for a regulator to walk in — not by preparing for six weeks, but by being ready always.
What you will do
- Own inspection readiness planning and execution for the site
- Run mock inspections and readiness assessments, and close the gaps
- Prepare and coach subject matter experts for inspection interviews
- Manage inspection logistics, front and back room, during live inspections
- Track commitments and responses through to closure
What success looks like at 12 months
A mock inspection has run with credible findings that got fixed, SMEs are prepared and confident, and readiness is a routine state rather than a project.
What we require
- Experience in GMP quality with direct regulatory inspection involvement
- Ability to assess a process the way an inspector would
- Skill at preparing people who are nervous to answer well
- Strong project coordination
What we would like, but will teach you
- Front room or scribe experience in an FDA inspection
- Multiple inspection types
- Experience of a bad inspection and what changed afterwards
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.
Hybrid — onsite at Bloomington, IN three days a week (Tuesday, Wednesday and one team-chosen day).
Pay and rewards
This role sits at grade 9, with a base range of $120,500 – $155,500 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
Our drug product and sterile fill-finish site. 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.