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GRAIL is a healthcare company pioneering early cancer detection using next-generation sequencing, population-scale clinical studies, and advanced data science. The company is headquartered in the Bay Area with locations in Washington D.C., North Carolina, and the United Kingdom.
This Senior Process Engineer - Compliance role is based in Durham, NC and reports into the quality and compliance function. You will lead and own quality management system (QMS) activities across the organization, including change controls, document control, SOP revisions, deviations/nonconformances, and corrective and preventive actions (CAPAs).
Key responsibilities include:
- Develop and maintain work instructions, guidelines, verifications, and standard operating procedures
- Independently investigate and resolve process deviations using root cause analysis and implement effective corrective and preventive actions
- Support internal audits, external inspections, and regulatory assessments; prepare documentation, evidence packages, and responses to audit observations
- Partner cross-functionally with Quality Assurance, Regulatory Affairs, Engineering Operations, Validation, and Clinical Operations leadership to implement and sustain compliant processes
- Identify process gaps, compliance risks, and operational inefficiencies; recommend and implement sustainable corrective actions and process improvements
- Mentor and train personnel on workflows, quality processes, and regulatory expectations
- Provide technical guidance and support to engineers and technicians to promote process understanding and standardization
- Prepare and present technical reports, proposals, and recommendations to management for process enhancements and cost savings
- Develop training compliance processes, including assignment, completion tracking, and on-the-job training assessments
The role involves work in office, laboratory, and manufacturing production environments with regular interaction with production equipment requiring PPE (safety glasses, gloves, lab coats, cleanroom garments). You will frequently stand, walk, and occasionally lift 25–30 lbs, with exposure to chemicals, noise, and temperature variations. Flexible hours, overtime, or weekend work may be required to support production or project deadlines.
REQUIREMENTS:
- Bachelor's degree in Engineering (Chemical, Mechanical, Industrial, or related field) with 5+ years of relevant experience, OR Master's degree with 3+ years of relevant experience, OR PhD with 2+ years of relevant experience
- Demonstrated knowledge of applicable regulatory standards commensurate with position complexity and scope, including: GMP quality management systems (e.g., ISO 13485), clinical laboratory regulations (e.g., CAP, CLIA, NYSDOH, ISO 15189), and operations within regulated medical device environments (e.g., IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
- Experience supporting audits, inspections, and regulatory readiness activities
- Proven ability to manage multiple priorities and drive projects to completion in a fast-paced regulated environment
PREFERRED QUALIFICATIONS:
- Strong working knowledge of quality management systems (QMS) and regulated laboratory/manufacturing operations
- Expertise in change control, CAPA management, deviation/nonconformance investigations, and document control processes
- Strong analytical and organizational skills with ability to manage metrics, trend data, and compliance reporting
- Excellent written and verbal communication skills, including technical writing and audit documentation
- Strong collaboration and stakeholder management skills across cross-functional teams
- Process improvement mindset with demonstrated success driving operational and quality improvements
- Experience executing within computerized maintenance/calibration equipment management systems
- Leadership skills to mentor junior engineers and lead cross-functional teams
- Strong project management and organizational skills to manage multiple workstreams with competing priorities
