Engineering Operations Manager - Compliance #3426

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
***WE STRONGLY ENCOURAGE OUR VETERAN COMMUNITY TO APPLY***
The Manager, Operations Engineering - Compliance will lead a key operations team that supports compliance throughout the entire lifecycle of manufacturing equipment with emphasis in Commissioning and Qualification.  Working cross-functionally with Operations, Research, Development, Quality, and Regulatory teams, they will drive robust equipment operations with a team of talented process and validation engineers. The successful candidate will be a leader with a proven track record of leading successful qualification projects, ensuring compliance with industry standards and regulations, and implementing and maintaining processes and programs that guarantee the quality and reliability of products.  GRAIL’s testing volumes are scaling fast and require a dynamic and detail-oriented leader to help deliver our revolutionary test to as many people as possible.
Expected schedule is on-site Monday to Friday.  This position may need to support weekends and holidays.  Alternative locations and work arrangements could be considered for the right individual.

You Will

• Build and manage a team of engineers with diverse scientific and technical skills required to support and maintain the equipment lifecycle program.
• Lead team of validation engineers that develop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring timely completion and alignment with organizational objectives.
• Establish and Maintain comprehensive documentation for equipment vendor specifications, internal developed (SOPs), training and program compliance.
• Support the timely handling of investigations, impact assessment, Change Controls, NCRs, deviations, and CAPAs.
• Lead area work responsibilities, effectively triage opportunities, direct work based on team skill set, and coach and guide staff to support the organization objectives following cGMP/GLP and Quality Management System (QMS) guidelines.
• Lead root cause investigations, drive for resolutions, and follow those up with corrective and preventative actions for areas of responsibility.
• Make time sensitive technical decisions.
• Ensure accurate and up-to-date records to support audits and regulatory inspections.
• Participate, be a role model, and adhere to GRAIL’s policies and guidelines.
• Recommend and implement changes to ensure ongoing high-quality performance of engineering processes as part of the continuous improvement process.
• Work closely with Quality and regulatory to implement and follow the required policies and procedures for system qualification, maintenance, and calibration

Your Background Should Include

• 8+ years of related experience with a BS/BA or higher degree in Engineering, Physics, Chemistry or Life Sciences or equivalent work experience.  Engineering degrees are preferred.
• Previous managerial experience in a similar work environment.  Experience managing multiple sites is preferred.
• Quality oversight experience of the equipment lifecycle program in a GxP environment.
• Demonstrated ability to successfully lead, coach, build, lead, and mentor engineers/technicians.
• Excellent communication skills to work as a leader and provide internal customer support.
• Excellent time management skills to support a fast paced working environment.
• Excellent troubleshooting and root cause analysis skills in both hardware and software.
• Strong experience with writing and implementing governing procedures, equipment documentation, test protocols and Master Validation Plans.
• Experience executing within a computerized maintenance/calibration management system.
• Knowledge Safety Training, lock out tag out (LOTO), Hazardous material, and waste handling.
• Strong hands-on experience in working knowledge and application of medical device and clinical laboratory regulations including SOX, CLIA/CAP, FDA 21 CFR part 820, ISO 13485, IVDR requirements.
• Project manag