Can biotech manufacturing/validation experience transition into QA/regulatory roles after a career gap?
A few years ago, after my PhD, I joined a large biotech company in a fairly senior scientist-level role on the manufacturing/verification-validation side, mainly supporting IVD-related validation, documentation, compliance, and cross-functional QA/QC/R&D activities.
I was impacted during a large layoff/restructuring and have been out of industry since mid-2023. Since then I’ve been adjunct teaching at community colleges, but now I’m trying to move back into industry, mainly toward QA/regulatory/compliance/validation-type roles rather than research-heavy R&D.
I’m currently considering the ASQ CQE certification and trying to understand how realistic this transition would be.
For people working in QA/regulatory/compliance:
Does my previous validation/manufacturing background sound transferable to QA or regulatory roles?
Does ASQ CQE actually help in biotech/pharma hiring?
Are remote/hybrid QA or regulatory roles realistic, or are most positions fully onsite?
What roles/titles should I realistically target to re-enter industry after this gap?
Would really appreciate honest advice from people already working in these areas.