Position Summary The Associate Director, GxP Systems will report to the Sr. Director, Commercialization Systems and will be responsible for leading the implementation, validation, and support of GxP-regulated systems to enable Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing in a commercial biotech environment. This role will play a pivotal part in supporting regulatory, compliance, and commercialization. The Associate Director will work with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M functions to ensure systems are fit‑for‑purpose, validated, and aligned with evolving business requirements.
Responsibilities
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
Qualifications
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 (e.g., 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
Compensation For this role, the anticipated base pay range is $165,000 - $220,000 USD.
Vera Therapeutics Inc. is an equal‑opportunity employer.
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