ERP Manager

This position can be 100% remote, but must be located in the United States.

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 Düsseldorf, Germany.

The Enterprise Resource Planning (ERP) Manager will play a pivotal role in driving the efficiency and effectiveness of our Dynamics 365 Finance and Supply Chain Management systems. This position is not just about maintaining our ERP environments; it's about transforming them to support our innovative and dynamic business operations. The ERP Manager will be the go-to expert for ensuring seamless integration and optimal performance of our ERP systems, particularly in finance, inventory, quality and manufacturing. With a strong proficiency in GxP and GAMP standards, the successful candidate will collaborate cross-functionally with IT, Finance, Quality, Operations, Vendors, and other critical business teams to implement best practices and drive continuous improvement. This role is essential for ensuring that our ERP systems not only meet but exceed the needs of our rapidly evolving business landscape.

Responsibilities

• Manage tickets and respond promptly to user issues. Accountable for change and incident request management, prioritization, resolution.
• Provide day-to-day support for our Dynamics 365 F&SCM User base and maintain our ERP Environments.
• Lead system upgrades ensuring minimal disruption to business processes. This includes coordination with our D365 Partner, coordination with our Business, Quality Assurance Processes and Project Management.
• Conduct thorough testing and automated testing using RSAT tool.
• Conduct regular system maintenance tasks to ensure optimal performance and compliance.
• Implement change control procedures adhering to SOX audit requirements and collaborate closely with Auditors and Business. Execute user access, roles, privileges, and security change requests and enhancements.
• Secure approvals, follow change management process and track functional changes needed for audit review.  Follow IT Policies.
• Develop disaster recovery plans to safeguard against unexpected events.
• Conduct training sessions for end-users on new features and updates.
• Support the implementation of new functionality and modules and assist users in defining business requirements, process maps, and use cases.

Qualifications

• Bachelor’s degree in Information Technology, Computer Science, a related field, or relevant industry experience; Master’s degree preferred.
• Minimum of 10 years’ experience with Dynamics 365 and AX functionalities.
• Expertise in finance, supply chain management (SCM), inventory management, and manufacturing within Microsoft D365 F&SCM.
• Solid applied knowledge of pharmaceutical industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GxP and GAMP 5 is preferred.
• Certification in Microsoft Dynamics 365 is preferred.
• Excellent analytical skills with attention to detail.
• Strong communication skills, both verbal and written.
• Proven ability to lead teams through complex projects.
• Ability to work under pressure while maintaining accuracy.
• Ability to work on-call, or respond after-hours as required to support Germany.
• German Language is a plus.
• 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.

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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.