Vera Therapeutics, Inc.

Operations

• Leads the manufacturing and supply chain teams, providing leadership aligned with Vera values resulting in a high performing organization.
• Contributes to the strategic leadership of Vera’s late-stage programs acting as a strong team player.
• Participate in sales and operations planning (S&OP) and Product Development Teams representing the Product Development and Manufacturing function.
• Create synergy and knowledge sharing to enable optimal production planning processes to balance supply/demand risks.
• Serves as a single point of contact to manage end-to-end global supply chain and foster the needed supplier relationships to drive excellence using appropriate metrics.
• Serves as a strategic thought leader to craft and manage commercial supply contracts with an eye towards life cycle extension programs.
• Create, develop and manage necessary tools for end-to-end demand/supply planning.
• Provide strategic direction, technical guidance, and long-range planning for late-stage programs: BLA-enabling studies through BLA submission, commercial launch, and sustaining operations.
• Develop and manage department budgets and ensure fiscal responsibility for manufacturing operations.
• Develop fit for purpose operational processes and systems to support supplier metrics and other tools to enable continuous improvement / process excellence.

Vice President, Commercial Manufacturing Operations

Director

• 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

Associate Director, GxP Systems

Human Resources

• Accountable for developing the People Strategy to enable both short-and-long term functional goals in alignment with Vera’s Corporate goals.
• Partner with HR subject matter experts to enable the People Strategy, specifically:
• TA to support attracting and hiring critical talent.
• Total Rewards to design compensation and benefits to support the hiring, retaining and recognition of employees.
• Employee relations to build people manager capability and ensure proactive management of performance.
• Communications to support change management and other initiatives.
• Talent development to support leadership growth and succession.
• Routinely assess the organizational needs as the business evolves to ensure the People Strategy is aligned to goals and meeting business needs.
• Advise and coach senior leaders in solving complex issues related to organization design, development, and change leadership.
• Participate and lead as appropriate corporate-wide programs that enhance the overall employee experience and support company growth and success overall.

Senior Director, HR Business Partner

Accounting Manager

• Prepare and book journal entries for month-end close, including sub-ledger/ schedule to ledger reconciliations and analysis of reconciling items.
• Prepare R&D and contract manufacturing (CMC) accrual journal entries based on executed contracts and communications with department leads or vendors, maintaining related workbooks and roll-forwards.
• Prepare and manage clinical trial accruals for select CROs and vendors, maintaining accurate accounting workbooks and ensuring proper tracking of expenses.
• Track and maintain monthly accruals and prepaids for assigned vendors and accounts, collaborating with department leads to ensure accurate recording based on contracts and operational needs.
• Track and prepare open Purchase Order accruals based on contracts and services provided, working with PO owners to ensure timeline and accurate month-end accruals.
• Prepare prepaids amortization of assigned accounts and maintain accuracy of subledgers, ensuring that subledgers are maintained accurately and consistently.
• Continuously evaluate processes and recommend improvements to enhance efficiency and effectiveness.
• Maintain a thorough and current understanding of general ledger structure and ensure integrity and accuracy of financial data.
• Assist with SOX 404 efforts in documenting and performing the key controls in areas of responsibility.
• Supporting improvement of accounting policies and procedures to drive operational efficiency.
• Assist with annual audits and quarterly reviews, preparing audit schedules, and other audit requests.
• Provide support for special projects, initiatives, and ad-hoc analyses, as needed, or requested.

Manager, Accounting

• Develop a strong business partner relationship with the Supply Chain Manufacturing, Quality, and Process Development functions.
• Prepare and manage cost accounting month-end close journal entries for prepaid manufacturing costs, raw materials, work-in-process and finished goods inventories, and cost of sales while maintaining subledger accounts, reconciliations to ensure compliance with U.S. GAAP.
• Own Inventory and COGS analytics and reporting, including development and maintenance of margin and variance analyses to support business decision-making.
• Support other month end close journal entries and reconciliations as opportunities arise.
• Work directly with contract manufacturing, supply chain, quality, internal & external audit to ensure accurate inventory, existence, valuation, and reporting completeness.
• Assist with SOX efforts in documenting and performing key controls in areas of responsibility.
• Represent inventory & cost accounting related to ERP and system enhancements and process improvements to strengthen data accuracy, automation, and internal controls.
• Continuously evaluate processes and recommend improvements to enhance efficiency and effectiveness.
• Maintain up to date accounting policies and desk procedures to drive operational efficiency.
• Assist with annual audits and quarterly reviews, preparing audit schedules, and other audit requests.
• Maintain a thorough and current understanding of general ledger structure and ensure integrity and accuracy of financial data.
• Potentially provide support for other functions such as revenue accounting, special projects, initiatives, and ad-hoc analyses, as needed.

Inventory & Cost Accounting Manager

• Oversee and work directly with CROs to provide guidance, effectively monitor and QC their deliveries for quality, time and budget adherence.
• Follow CDISC SDTM and ADaM standards and guidelines; validate SDTM, ADaM datasets and TFLs generated by the CRO.
• Work with the internal teams and CRO to prepare submission-readiness datasets (e.g. SDTMs, ADaMs) and metadata to support the BLA filing.
• Hands-on statistical programming to support CSR, publications, presentations, DSUR, IB update, safety data review, RTQ, and ad hoc analyses.
• Attend SMT and collaborate with the study statistician and other study team members in project planning and timeline discussions.
• Review key study documents including but not limited to study protocol, SAP, and CDM documents like CRF and DTA and provide inputs to represent statistical programming function.
• Work collaboratively with stakeholders and other developmental functions to standardize, maintain, and implement the data transformation and statistical analysis requirements.
• Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
• Familiar with SAS server working environment and adherent to server and programming SOP.
• Proficiency in R for statistical analysis, data analysis, modeling, and data visualization

Associate Director, Statistical Programming

QA Engineer

• Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements.
• Responsible for implementing strategies and tactics to promote and maintain GxP compliance.
• Lead quality aspects of and provide quality support on DP tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of commercial and clinical DP/ combination products.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc.
• Provides assistance during both internal and regulatory agency audits as required
• Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Lead for Quality Agreement with external partners.
• Support product lifecycle and continued process verification.
• Availability for 10-20% travel, both domestically and internationally.

Senior Manager, Quality Assurance

Marketing

• Solicit disease state and brand insights through field-based, 1:1 KEE engagements and gather and share these insights with internal partners to inform brand strategy.
• Organize and moderate regional and national advisory boards to fully understand the customer and patient perspective.
• Actively collect, analyze, and synthesize information on KEE sentiments, competitor activities, and broader market trends from diverse sources (1:1 meeting, advisory boards, congresses).
• Aid in the development and execution of commercial-led advisory boards and other third-party insight gathering tactics.
• Track KEE beliefs over time on Vera, the IgAN treatment landscape, unmet clinical needs, and patient management based on podium presentations, social media activity, scientific publications, and 3rd party educational programs.
• Create and execute an objective-based KEE advocacy building plan to include the identification and curation of relationships with established and emerging KEEs in the academic and community-based settings to support the development of US KEE champions within IgAN.
• Responsible for cultivating and developing KEEs over time who are experts in IgAN.
• Act as the face of Vera’s commercial organization and drive impact through personalized 1:1 interactions and focused small group meetings.
• Identify, recruit and train members of Vera’s inaugural US Speaker Bureau.
• Develop and execute comprehensive Congress plans to include international, national, and regional conferences, and society meetings within an assigned geographic area.
• Build out peer-to-peer education platform with unique offerings that will drive awareness of IgAN, the role of BAFF/APRIL and Atacicept.

Associate Director, Regional Marketing – Mid-Atlantic

• Provide oversight of Trial Master File management across clinical development programs and functions.
• Partner closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained within the TMF.
• Facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations.
• Interface with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization.
• Support TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements.
• Establish and maintain consistent TMF management practices across studies and programs.
• Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation.
• Oversee quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies.
• Develop and track eTMF metrics for studies and communicate trends or issues identified to study teams and management.
• Serve as the eTMF system administrator, supporting user access management, system configuration support, troubleshooting, and ongoing optimization of system functionality.
• Support regulatory inspections and internal audits involving TMF records and management.
• Collaborate with the Head of Clinical Quality Assurance and system users to identify opportunities to improve TMF processes, system functionality, and inspection readiness practices.
• Work with the eTMF system owner and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.