Quest Diagnostics · 3 months ago
Manager, Test Code Maintenance (Remote)
United States
Full-time
Remote
Mid, Senior Level
5+ years expQuest Diagnostics is a leading provider in the healthcare industry, and they are seeking a Manager for Test Code Maintenance. This role involves leading the development and documentation of GxP compliant processes for test code management while managing a remote team across multiple time zones.
BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine
Responsibilities
Develop, document and maintain the following processes in compliance with the appropriate GxP regulations and the Pharma Services QMS system
Test Code Creation (TCC) intake
TCC prioritization, scheduling & assignment
TCC design and approval
TCC development and validation
TCC approval and release
Provide QCTMS production support, creating and maintaining test codes, while developing resource plan and building out the team
Oversee and guide the TCC team, once in place, to implement new and updated test codes throughout the test code lifecycle
Work with Pharma Services Proposals, Project Management, Data Management and Senior Leadership to prioritize and maintain a published schedule of test code deployments
Follow test updates from partner laboratories and assess when updates are required to the test compendium
Work with partner lab teams and IT to ensure test information is appropriately routed between systems
Work with partner lab and medical teams to ensure test information is appropriately displayed on laboratory reports
Aid in the due diligence of future selection of partner labs by providing assessment of their test compendium and how it maps to the Pharma Services test compendium
Other duties as assigned
Qualification
Required
5+ years of experience in laboratory, biopharma, and/or diagnostic industry in multiple lab disciplines, working with an automated Laboratory Information Systems
Direct leadership of internal and/or external resources managed remotely
Travel: Domestic up to 25; international up to 25%
A bachelor's degree or higher or equivalent experience
English required
Knowledge of laboratory testing processes
Knowledge of regulatory frameworks associated with clinical laboratories and clinical trials, such as CAP, CLIA, GxP and 21CFR Part 11
Understanding of system integrations
Understanding of data transfers
Ability to manage complex cross-functional projects
Critical thinking and problem-solving skills
Quantitatively inclined
Strong communications
Preferred
3+ years working on supporting and/or administrating a healthcare informatics system in a clinical or diagnostics lab environment
Master's Degree or Equivalent
Company
Quest Diagnostics
Quest Diagnostics is a clinical laboratory that offers diagnostic testing, services, and information.
10001+ employees
H1B Sponsorship
Quest Diagnostics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (59)
2024 (38)
2023 (74)
2022 (56)
2021 (49)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$2.6B2024-08-15Post Ipo Debt· $1.85B
2023-10-30Post Ipo Debt· $750M
1996-12-17IPO
Leadership Team
James Davis
Chief Executive Officer and President
Cecilia McKenney
SVP & Chief Human Resources Officer
Recent News
2026-01-06
Company data provided by crunchbase