Job Description

This is a hands-on, lead from the front, position that will require the development and documentation of GxP compliant processes to maintain all aspects of test code management for the Pharma Services group. You will be required to perform these procedures, while creating the team’s resource requirements as the business grows.  Once the resource plan is executed you will manage the team remotely across multiple time zones and potentially internationally.

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) intakeTCC prioritization, scheduling & assignmentTCC design and approvalTCC development and validationTCC approval and releaseProvide 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 lifecycleWork 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 compendiumWork with partner lab teams and IT to ensure test information is appropriately routed between systemsWork with partner lab and medical teams to ensure test information is appropriately displayed on laboratory reportsAid 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


Qualifications:

Required Work Experience: 

5+ years of experience in laboratory, biopharma, and/or diagnostic industry in multiple lab disciplines, working with an automated Laboratory Information Systems.

Preferred Work Experience: 

3+ years working on supporting and/or administrating a healthcare informatics system in a clinical or diagnostics lab environment.

Physical and Mental Requirements: 

Office work and periodic travel

Knowledge: 

Knowledge of laboratory testing processes.Knowledge of regulatory frameworks associated with clinical laboratories and clinical trials, such as CAP, CLIA, GxP and 21CFR Part 11Understanding of system integrationsUnderstanding of data transfers 

Skills: 

Ability to manage complex cross-functional projectsCritical thinking and problem-solving skillsQuantitatively inclinedStrong communications

Required:

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

Preferred:

Master’s Degree or Equivalent

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