Associate Director, GxP Systems

Title: Job Title: Associate Director, GxP Systems

Location: Brisbane, California

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do, from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

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, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a pre-commercial biotech environment.

This role will play a pivotal part in supporting regulatory, compliance, and operational readiness for commercial launch.

Working 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:

• Will be responsible for system oversight for the selection, implementation, and lifecycle management of GxP systems (e.g., eQMS, RIM, TraceLink) supporting core business functions during pre and post product launch.
• Lead cross-functional system implementation projects, including vendor selection, requirements gathering, configuration, testing, and deployment.
• Partner with QA to develop and maintain Computer System Validation (CSV) documentation per GAMP5 and 21 CFR Part 11 requirements, ensuring audit readiness and regulatory compliance.
• Collaborate with internal IT teams and external vendors to design and deploy system integrations and data flows that support end-to-end process automation and reporting.
• Develop and maintain system documentation, including user requirements, configuration specifications, and validation deliverables, SOPs, training materials, and work instructions in collaboration with Quality and business stakeholders.
• Administer GxP systems, including user access management, role-based controls, and audit trail reviews, ensuring compliance with IT security and data integrity policies.
• Lead and coordinate change management processes, including impact assessments, change control documentation, testing, and release planning for GxP system.
• Provide IT support for audits and inspections related to GxP systems, acting as the subject matter expert on technical architecture, validation status, and system controls.
• Drive continuous improvement and scalability of systems to meet the needs of a growing, transitioning organization moving toward commercial readiness.
• Translate business needs into scalable technical solutions and act as a bridge between functional stakeholders and technical teams (internal and external).
• Develop and track project plans, budgets, and resourcing for GxP and other Business System IT initiatives.
• Manage risks and ensure timely delivery of milestones.
• Provide daily support for system-related inquiries, ensuring compliance and operational efficiency.

Qualifications:

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred.
• 8+ years of experience managing GxP systems in life sciences, with at least 2–3 years in a leadership or strategic role.
• Proven experience implementing and validating systems such as Veeva Vault (QMS, RIM, eTMF), TraceLink, 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 supporting or leading systems in pre-commercial and early-stage biotech companies as they transition to the commercial stage.
• Demonstrated ability to work effectively across functions, including IT, QA, Regulatory, and Technical Operations.
• Excellent project management skills and experience managing vendors, consultants, and implementation partners.
• Ability to operate with agility in a fast-paced, dynamic environment while maintaining a high level of compliance and attention to detail.
• Strong analytical and communication skills with the ability to clearly convey technical information to non-technical stakeholders and influence decision-making.

Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.

For this role, the anticipated base pay range is 186,000.00- $211,000.00. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package.

The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.

Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

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