tarsusrx

tarsusrx

Manager II, Enterprise Applications (R&D & GxP Systems)

Irvine, California, United States · Mid

Sponsorship not specified$134k-$188kDetected 53 days ago
GCPProject ManagementAgileCommunicationCollaborationProblem SolvingPublic SpeakingGxP

About the role

  • Let's talk about some of the key responsibilities of the role:
  • Act as a subject matter expert and IT system owner for assigned GxP applications, including Veeva Vault platforms and other validated systems supporting Clinical, Regulatory, Quality and other regulated functions
  • Assist with data management, migration, integration, and analytics across GxP systems, ensuring business needs are met

Responsibilities

  • Collaboration and Team Building
  • Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
  • Collaborate with business stakeholders, IT, Quality and external vendors to implement new systems and provide day-to-day operations support for assigned GxP systems
  • Coordinate and support validation testing including user acceptance testing (UAT) of system changes and ensure quality production deployments
  • Manage periodic reviews, upgrades and releases including release assessments.
  • Collaborate with cross-functional teams and support the business stakeholders to identify and implement process improvements, enhancing system efficiency and effectiveness
  • Experience managing vendors, system integrators, and SaaS providers in both project and support contexts

Requirements

  • Review and own IT activities for change control requests and provide all required documentation for GxP systems
  • Some travel may be required - up to 10%

Nice to have

  • Bachelor's degree in Computer Science, Information Systems, Engineering, Quality, Regulatory, or Business, with 8+ years of relevant IT experience in the life sciences or pharmaceutical industry
  • 6+ years of experience implementing and supporting GxP systems, including clinical, regulatory, quality and other GxP applications
  • Solid understanding of business processes, System Development Lifecycle (SDLC) and validation in a GxP-regulated setting, including strong knowledge of 21 CFR Part 11, EU Annex 11, and GxP compliance practices
  • familiarity with ICH GCP regulations is a strong plus
  • Hands-on experience with Veeva Vault applications (e.g. RIM, CTMS, eTMF ) strongly preferred
  • certifications in Veeva Vault modules are a plus
  • Experience working with a QMS, GxP LMS systems or other GxP systems is a plus
  • Working knowledge and familiarity with statistical tools (e.g., Minitab, JMP)

Compensation

  • The expected base pay range for this position is $134,200 - $188,000 plus bonus, stock equity, and comprehensive benefits.

Benefits

  • Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
  • The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.

Equal opportunity

  • Equal Opportunity Employer.
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