Senior Process Engineer, QMS & Compliance

Grailbio

Durham (NC)

On-site

USD 95,000 - 125,000

Full time

5 days ago

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Job summary

GRAIL is seeking a Senior Process Engineer to lead complex quality management activities across engineering, validation, clinical labs, and operations. You will drive change controls, document control, SOP updates, NCs and CAPAs, while mentoring staff and ensuring regulatory readiness in a high‑stakes environment.

The role emphasizes advanced technical expertise in molecular diagnostic workflows for the Galleri assay, with onsite work in Durham, NC.

Qualifications

Bachelor’s degree in Engineering with 5+ years of relevant experience (or MS with 3+ years, or PhD with 2+ years).
Regulatory standards knowledge including GMP/ISO 13485, CAP/CLIA, and FDA guidelines.
Experience supporting audits, inspections, and regulatory readiness activities.
Strong QMS, CAPA, deviation investigations, and document control experience.
Proven ability to manage multiple priorities in a fast-paced regulated setting.

Responsibilities

Lead QMS activities: change controls, document control, SOP revisions, NCs and CAPAs.
Develop and maintain work instructions, guidelines, verifications, and SOPs.
Investigate process deviations with root cause analysis and corrective actions.
Support internal audits, inspections, and regulatory assessments with evidence packages.
Collaborate cross-functionally to sustain compliant processes in QA, Regulatory, Engineering, and Operations.