This position is a leader within the Quality Operations organization, responsible for establishing, implementing, maintaining, and improving the quality operations elements of GRAIL’s quality management system. This position interacts with departments throughout the organization including but not limited to Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain, Manufacturing, and Research & Development. The person in this role consistently applies critical thinking skills and good judgment to independently and proactively identify and solve broad, complex problems, effectively cascading functional strategy and decisions across teams and communicating status and recommendations to senior management.

Responsibilities

• Lead medical device quality operations through interpretation, establishment, and execution of quality principles and concepts in accordance with GRAIL’s quality management system and regulatory requirements including ISO 13485, In Vitro Diagnostic Regulation, ISO 14971, 21 CFR 11, 21 CFR 820.

• Work on abstract problems across functional areas of the business.

• Identify and evaluate fundamental issues and resolutions for major functional areas through assessment of intangible variables.

• Interact with executive level management requiring negotiation to influence policy and decision-making.

• Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.

• Operate as a capable strategic people and thought leader.

• Acceptance Activities including incoming reagent material inspections, specimen collection kit inspections, and manufactured reagent DHR review and product release

• Support warehouse controls including identification and traceability

• Support facilities and equipment qualifications

• Support manufacturing process validations and QC test method validationsOn-market product DMR/MDF/RMF updates

• Ensure high-quality execution of quality processes including NCRs, CAPAs, planned temporary deviations, and change management workflows

• Generate and analyze Quality Indices metrics and Quality Management Review metrics

• Provide guidance to other departments and serve as subject matter expert (SME) on applicable regulations and standards.

• Support the Quality, Regulatory, and Compliance functions ensuring a unified QA/RA/Compliance commitment to achieving established goals and objectives.

• Represent Quality Operations on sanctioned cross-functional projects driving toward effective, on-time completion of business goals and objectives.

• Drive a culture of quality across the organization with the goals of efficiency, compliance, and continual improvement.

Preferred Qualifications:

• Bachelor’s or Master's degree in a related technical area, or MBA or equivalent

• 8 + years of experience working within a medical device, pharmaceutical, or biotech regulated quality management system.

• Strong knowledge and implementation of applicable regulations and standards including but not limited to IVDR, 21 CFR 820, ISO 13485, ISO 14971, and 21 CFR 11.

• Proven leadership, organizational and management skills to coordinate cross-functional decision making.

• Experience preparing for, leading, and supporting regulatory inspections/audits and effectively responding to findings.

• Excellent written and verbal communication skills.

• Ability to comprehend and interpret technical information related to analytical methods, processes, and regulatory requirements.

• Next Generation Sequencing (NGS) experience.

• Clinical laboratory QMS experience including ISO 15189, 21 CFR Part 493 (CLIA), CAP, New York State Department of Health (NYSDOH).

• ASQ Certified Quality Auditor, Certified Quality Engineer, or similar.