Associate Director, GxP Systems

Vera Therapeutics, Inc.

Associate Director overseeing GxP Systems implementation and validation at Vera Therapeutics. Leading compliance efforts for Quality Assurance, Regulatory, and Clinical operations in a commercial biotech environment.

Posted 5/27/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $145,000 - $220,000 per yearWebsite

Tech Stack

Tools & technologies

ERPOracle

About the role

Key responsibilities & impact

Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred
10-12 years of hands-on experience with GxP systems in Life Sciences, including system administration, validation oversight, and operational support
Proven experience implementing and validating systems such as eQMS, TraceLink, LMS, Validated Documents and Data storage solutions (such as Box for GxP or Egnyte Life Sciences), or ERP systems (e.g., NetSuite, Oracle, SAP) in a GxP-regulated environment
Strong understanding of CSV, data integrity, Part 11 compliance, and regulatory expectations (FDA, EMA, ICH)
Experience partnering with validation/CSV resources while maintaining accountability for system compliance and validation outcomes
Proven experience owning and managing Change Control processes for GxP systems
Experience supporting pre-commercial biotech organizations transitioning to commercialization
Ability to balance strategic oversight with hands-on system administration and operational responsibilities
Strong cross-functional collaboration skills across IT, QA, Regulatory, and Technical Operations
Experience managing vendors and implementation partners
Excellent troubleshooting, analytical, and problem-solving skills
Strong communication skills with the ability to translate technical concepts into business terms and influence stakeholders.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Vera Therapeutics, Inc. Website LinkedIn All Job Openings 201 - 500 employees 🧬 Biotechnology 💊 Pharmaceuticals Biotechnology
Pharmaceuticals Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability. Associate Director, GxP Systems 🔥 0 minutes ago 🇺🇸 United States – Remote 💵 $145k - $220k / year ⏰ Full Time 🟠 Senior 👔 Director Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives 🎯 Requirements
Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred
10-12 years of hands-on experience with GxP systems in Life Sciences, including system administration, validation oversight, and operational support
Proven experience implementing and validating systems such as eQMS, TraceLink, LMS, Validated Documents and Data storage solutions (such as Box for GxP or Egnyte Life Sciences), or ERP systems (e.g., NetSuite, Oracle, SAP) in a GxP-regulated environment
Strong understanding of CSV, data integrity, Part 11 compliance, and regulatory expectations (FDA, EMA, ICH)
Experience partnering with validation/CSV resources while maintaining accountability for system compliance and validation outcomes
Proven experience owning and managing Change Control processes for GxP systems
Experience supporting pre-commercial biotech organizations transitioning to commercialization
Ability to balance strategic oversight with hands-on system administration and operational responsibilities
Strong cross-functional collaboration skills across IT, QA, Regulatory, and Technical Operations
Experience managing vendors and implementation partners
Excellent troubleshooting, analytical, and problem-solving skills
Strong communication skills with the ability to translate technical concepts into business terms and influence stakeholders. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Associate Director, Analytical Sciences, Attribute Characterization 🔥 30 minutes ago Spyre Therapeutics 11 - 50 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings Associate Director overseeing structural and functional characterization in biotechnology for inflammatory bowel disease and rheumatic diseases. Leading teams in analytical development and regulatory submissions. 🇺🇸 United States – Remote 💵 $175k - $190k / year ⏰ Full Time 🟠 Senior 👔 Director Senior Director, National IKC 🔥 1 hour ago DaVita Kidney Care 10,000+ employees ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Sr. Director of National Support leading non-clinical operations for renal care management at DaVita. Requires operational leadership and call center experience, focusing on quality and performance metrics. 🇺🇸 United States – Remote 💵 $115k - $183k / year 💰 Post-IPO Debt on 2021-02 ⏰ Full Time 🟠 Senior 👔 Director Associate Director, Health Technology Consulting, Revenue Cycle Technology – Meditech 🔥 6 hours ago Guidehouse 10,000+ employees Website LinkedIn All Job Openings Associate Director leading revenue cycle technology engagements across Commercial Health client portfolio at Guidehouse. Serving as a senior advisor to health system executives in technology work. 🇺🇸 United States – Remote 💵 $135k - $225k / year 💰 Grant on 2023-02 ⏰ Full Time 🟠 Senior 👔 Director 🦅 H1B Visa Sponsor Senior Director, Field Clinical and Procedural Excellence 🔥 7 hours ago Abbott 10,000+ employees ⚕️ Healthcare Insurance 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings Lead Field Clinical organization at Abbott Structural Heart for clinical trials and training. Drive operational excellence with strong leadership and strategic oversight in cardiology. 🇺🇸 United States – Remote 💵 $171.3k - $342.7k / year ⏰ Full Time 🟠 Senior 👔 Director 🦅 H1B Visa Sponsor Senior Director, Medical Affairs 🔥 10 hours ago ORIC Pharmaceuticals Inc. 51 - 200 🧬 Biotechnology ⚕️ Healthcare Insurance 💊 Pharmaceuticals Website LinkedIn All Job Openings Senior Director of Medical Affairs at ORIC Pharmaceuticals driving medical strategy and execution for oncological therapies. Building key global capabilities and leading scientific engagement activities. 🇺🇸 United States – Remote 💵 $300k - $340k / year ⏰ Full Time 🟠 Senior 👔 Director View More Director Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

GxP systems administrationComputer System Validation (CSV)Change Control processessystem implementationdata integrityregulatory complianceeQMSvalidated documentsERP systemstroubleshooting

Soft Skills

cross-functional collaborationanalytical skillsproblem-solving skillscommunication skillsstrategic oversightinfluencing stakeholdersvendor managementproject managementrisk evaluationcontinuous improvement