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Director, ERP
Emeryville, CA
Job Description
Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment of public health. Our proprietary CpG 1018 adjuvant powers our diversified infectious vaccine portfolio, which includes HEPLISAV-B, our commercial product approved in the U.S. and the European Union, for prevention of hepatitis B virus in adults. We also supply CpG 1018 to research collaborations and partnerships globally. Currently, CpG 1018 is being used in development of COVID-19, plague, shingles, and Tdap vaccines.
At Dynavax, our vision and work ethic are guided by the collective ideals underpinning our core values, and these form the basis of our dynamic company culture. We strive to maintain a culture where each employee is valued by the organization and where our organization is valued by each employee. We offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessary. Dynavax is headquartered in the San Francisco Bay area, and our manufacturing facility is in Dusseldorf, Germany.
The primary responsibilities of the position are to: (i) set strategy, plan, and manage the lifecycle and compliance for enterprise ERP systems; (ii) partner with Dynavax IT leadership and business stakeholders to develop a plan for enterprise ERP systems globally. Responsible for managing the compliance program for enterprise ERP systems. The Director, ERP will partner, collaborate, and align with business colleagues to define and document critical business processes and requirements, prioritize requests, create business cases for technology solutions, and manage them through the IT governance process to drive planning, implementation, and support of enterprise ERP applications including but not limited to Dynamics 365 and integrations with other platforms including JP Morgan, Dooap, Auxilius, Vena, FloQast.
The Director, ERP is responsible for ensuring high level expert, technical support and consultation to the business and IT management, oversees day-to-day system administration, solution configuration, customizations, security, SOX compliance, support, integrity, and management of Microsoft Dynamics 365 and other associated platforms. The role also oversees vendors providing services and serves as the primary point of contact and planning with external service providers overseeing their activities and performance.
As a strong business partner to multiple business functions, the Director, ERP understands business challenges and opportunities and works to lead the design, configuration, and maintenance of value-added solutions to meet the set business requirements. The role acts as project owner for key and significant ERP-related efforts, guiding the strategy, planning, implementation and transition to support for new capabilities.
Responsibilities- Strategy, Design and Delivery:
- Partner with Dynavax IT and business partner leadership to select, plan, design, install, and document ERP Systems in alignment with industry best practices and established Dynavax Quality Directives and SOP's.
- Support governance processes which oversee and deliver critical IT projects and operations. Member of Governance Committees representing ERP systems.
- Collaborate with Dynavax IT and business partner leadership to develop the technology strategy, budget, and roadmap for Dynavax ERP Systems.
- Provide implementation and technical consultation of new corporate ERP information systems to support the line organization as needed. Serve as Project Manager for technology implementations, including coordination and management of external vendors and ensuring adherence to corporate SOPs.
- Oversees SOX and GxP compliance as it relates to ERP systems, including continuous improvement of the compliance program.
- Coordinate with Dynavax's manufacturing plant in Dusseldorf, Germany on the plant's ERP information systems as needed to facilitate alignment on processes, technologies, and common practices.
- Manage relationships with vendors and external service providers, ensuring high quality service delivery and escalation of challenging issues when appropriate.
Systems Oversight and Personnel Management:
- Organize and execute analysis, design/configuration, implementation and delivery of the finance and supply chain modules during Microsoft recommended Dynamics 365 update cycle implementations. Manage processes required to plan and deliver changes and upgrades.
- Plan significant projects, upgrades, and changes in coordination with business leadership and external support.
- Accountable for relationship with 3rd party vendors, operating as primary point of contact for planning, escalations, and day-to-day operations. Manage escalation process and jointly troubleshoot issues.
- Oversee change and incident request management, prioritization, resolution.
- Management and direction of IT staff responsible for providing ongoing technical and application support to business units.
- Maintain strong coordination with business users, overseeing planning, testing, training, and delivery of changes.
System Administration and Support:
- Oversee system administration of D365 F&O GL, AP, Supply Chain and Reporting functions.
- Oversee user access, roles, privileges, and security enhancements.
- Investigate problems with D365 modules, diagnose root causes, and resolve issues.
- Facilitate integrations between ERP and other systems following industry best practices.
- Support user 'how-to' questions, walk through D365 steps and train users as needed.
- Analyze business process issues and improvements and provide solution recommendations to Finance and IT management in a timely manner.
- Provide weekly project status reports and milestone target schedules.
- Process and Project Management:
- Documents and assist users in defining business requirements, process maps, and use cases.
- Secure approvals, follow change management process and track functional changes needed for audit review. Follow IT Policies.
- Functional and technical requirement gathering, gap analysis and documentation on MS Dynamics D365. Investigate feature requests, clarify objectives, understand software functionality, and recommend solutions using industry best practices.
- Analyze and document current and future system processes.
- Prepare Function Design Documents as part of necessary configuration or development changes/needs.
- Configure Dynamics 365 modules to meet periodic business requirements.
- Manage project tasks to implement enhancements and functional changes.
- Facilitate testing and prepare documentation for approval.
- Define and build various Power BI reports to support the business teams.
- Assist the programmers and developers through designing, programming, testing, deploying, maintaining, and supporting User initiatives.
- Maintain system of internal controls, perform periodic testing and document procedures and results in accordance SOX requirements.
- Project oversight and reporting for requested projects.
- BA or BS degree in Computer Science/Information Systems or equivalent experience
- Minimum of 12 years Microsoft Dynamics D365 and/or AX /2012 ERP Systems support experience. Experience with Remote Server Administration Tools (RSAT) for Windows, Azure DevOps, Agile and Continuous Improvement/Continuous Delivery frameworks and implementation.
- 2-3 years of experience leveraging IT service management tools to ensure service delivery (e.g., Jira, Confluence, and Service Now).
- Demonstrated experience managing 3rd party software support services and working with teams of developers.
- Experience managing changes in highly controlled and regulated environments, including SOX, ERP, 21CFR.
- Solid applied knowledge of pharmaceutical industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, and GAMP 5.
- Hands on experience in diverse areas including planning, implementation, migration, training & troubleshooting of significant system changes and upgrades.
- Excellent organization and time management skills, ability to prioritize demands and multi-task to complete objectives. Ability to be flexible and creative.
- Personnel management skills, including guiding technical resources in delivery of high-quality services.
- Ability to build relationships with our internal and external partners/customers.
- Demonstrate integrity, maturity, and a constructive approach to challenges.
- Excellent communication, project management & presentation skills.
- Ability to work on-call, or respond after-hours required to support Germany.
- Ability to sit; stand; walk; reach with arms and hands; lift and move small objects; and use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.
- Occasional travel required, as needed.
- The estimated salary range for this position is $210,000 to $225,000. Final pay determinations may depend on various factors, including, but not limited to experience level, education, geographical location, knowledge, skills, and abilities. The total compensation package for this position also includes other compensation elements such as stock equity awards and participation in our Company's discretionary annual bonus program. Dynavax also offers a full range of health and welfare insurance benefits, 401(k) company match, and paid time off benefits, including 17 paid holidays in 2024.
#LI-REMOTE
Please click the link below to view the Dynavax Privacy Notice:
Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. Dynavax complies with The Americans with Disabilities Act (ADA) and the Americans with Disabilities Amendments Act (ADAAA). If you have a disability and feel you may need an accommodation in connection with the on-line application process, please email us at HR@dynavax.com.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
12+ years
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