Associate Director, Quality Labeling Operations # 4648

GRAIL•Durham, NC

96d•$146,000 - $194,000•Hybrid

About The Position

GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. The Associate Director, Quality Labeling Operations is responsible for establishing, implementing, maintaining, and continuously improving GRAIL’s product labeling program. This role partners closely with Regulatory Affairs, Operations, Marketing, Supply Chain, R&D, Clinical Laboratory, Clinical Operations, and Design/Artwork to lead the global product labeling controls for GRAIL’s regulated in vitro diagnostic (IVD) medical devices. This individual contributor role is the SME responsible for the development, implementation, and lifecycle management of compliant product labeling content, including Instructions for Use (IFU), Unique Device Identifier (UDI) labeling, and other product labeling elements required under FDA, EU IVDR/MDR, and U.K. MHRA regulations. The individual applies critical thinking and sound judgment to solve broad, complex problems and regularly communicates status, risks, and recommendations to management. Primary responsibilities include providing expertise and oversight to ensure GRAIL’s product labeling operations achieve and maintain compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485:2016, ISO 14971:2019, 21 CFR 801, 21 CFR 820, 21 CFR 809, Unique Device Identifier (UDI) requirements and related in vitro diagnostic medical device regulations.

Requirements

BS/BA degree & 10+ years of related experience, or Masters & 8+ years of related experience, or PhD & 5+ years of related experience.
Working knowledge of applicable medical device regulations and standards including but not limited to 21 CFR 801, 21 CFR 809, 21 CFR 820, ISO 13485:2016, ISO 14971:2019, MDR/IVDR.
Experience establishing and implementing medical device UDI, compliant with both FDA and EU regulations.
Proven expertise remediating and improving a medical device labeling process to ensure an effective, compliant, inspection-ready program.
Experience using an eQMS required; Veeva Vault preferred.
Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner.
Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.
Experience supporting regulatory inspections/audits and responding to findings.
Expertise managing data reporting and communications using tools including Smartsheet, Confluence, Google Docs and Google Slides.
Proven leadership, organizational and management skills to drive effective, compliant cross-functional decision making.
Excellent written and verbal communication skills and attention to detail.
Ability to comprehend and interpret technical information related to GRAIL's product claims.
Experience preparing for, leading, and supporting FDA and EU Notified Body regulatory inspections/audits and effectively responding to findings.

Nice To Haves

BS/BA degree & 12+ years of related experience
ASQ Certified Quality Auditor, Certified Quality Engineer, or similar preferred.
Experience working within a clinical laboratory (high complexity CLIA/CAP environment, compliant with ISO 15189) preferred.
Next Generation Sequencing (NGS) experience preferred.

Responsibilities

Serve as the primary process owner for product labeling operations activities within the Quality Management System (QMS).
Establish, maintain, and improve product labeling processes, procedures, and infrastructure (including electronic labeling systems, proofing, and physical and electronic distribution controls).
Establish and maintain labeling specifications and source artwork files (printed and electronic).
Ensure all product label claims are substantiated through the Design History File in partnership with Regulatory, Design Quality, and Research, Design, and Operations teams.
Partner with Marketing and Regulatory teams to align product labeling controls with advertising/promotional labeling controls, which are managed by the Promotional Material Review Committee and led by Marketing.
Initiate and support Veeva change control workflows for product labeling specifications which evaluate design history file (DHF) and risk management file (RMF) impacts.
Maintain inspection-ready product labeling documentation and traceability between product labeling, risk files, and technical documentation.
Ensure only current, approved product labels are distributed in print and electronically.
Drive cross-functional alignment and governance for labeling, ensuring Regulatory, Legal, and Clinical Study content oversight and compliant execution.
Manage label verification and validation, including proof review, barcode functionality, and compliance with UDI, GUDID, and GS1 requirements.
Provide direction to cross-functional teams on product labeling compliance requirements.
Align global core product labeling with regional requirements while supporting local adaptations for major markets.
Represent the Product Labeling Program as Subject Matter Expert during audits and inspections.
Monitor global regulatory changes and lead labeling process updates to maintain compliance that is aligned with our Commercial strategy.