The role
You will own the CAPA system — making sure corrective actions are real, effective and actually completed.
What you will do
- Manage the CAPA lifecycle from initiation through effectiveness check
- Challenge weak actions before they are approved
- Track completion and escalate overdue items
- Assess and report CAPA effectiveness with evidence
- Report CAPA metrics to site quality leadership
What success looks like at 12 months
Overdue CAPAs are near zero, effectiveness checks are evidence-based, and weak actions are being rejected before approval rather than after failure.
What we require
- Experience with quality systems in a regulated environment
- Ability to distinguish a real corrective action from a training slide
- Strong organisation and follow-up
- Comfort holding senior people to commitments
What we would like, but will teach you
- QMS platform experience such as Veeva or TrackWise
- Root cause analysis training
- Audit or inspection experience
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 Devens, MA three days a week (Tuesday, Wednesday and one team-chosen day).
Pay and rewards
This role sits at grade 7, with a base range of $95,500 – $123,000 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
Our largest manufacturing site, running drug substance 24/7. 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.
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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.