Associate Director, Quality Labeling Operations

GRAIL

Associate Director overseeing product labeling operations for GRAIL, a healthcare company advancing early cancer detection technologies. Leading compliance and regulatory initiatives for product labeling within Quality Management System.

Posted 6/9/2026full-timeDurham • North Carolina • 🇺🇸 United StatesSenior💰 $146,000 - $194,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

product labelingQuality Management System (QMS)labeling specificationsDesign History File (DHF)risk management file (RMF)label verificationlabel validationUDI compliancemedical device regulationsISO 13485:2016

Soft Skills

leadershiporganizational skillsmanagement skillsattention to detailcommunication skillsability to work under pressuremeticulous workcross-functional decision makingcomposed mannerability to interpret technical information

Tools & Technologies

Veeva VaulteQMSSmartsheetConfluenceGoogle DocsGoogle Slides

Certifications & Qualifications

BS/BA degreeMasters degreePhD

Industry Keywords

21 CFR 80121 CFR 80921 CFR 820ISO 14971:2019MDRIVDRregulatory inspectionscomplianceadvertising labeling controlsproduct claims

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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.
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

flexible time-off or vacation
401(k) retirement plan with employer match
medical, dental, and vision coverage
carefully selected mindfulness programs