- Maintains adherence of ERP functional and applications architecture. This to ensure IT systems meet required service levels and adherence with policies and procedures for compliance including GxP, GDPR, CSV, HIPAA, and SOX.
- Working with GxP change management, release management, and validation of configuration changes across multiple environments, ensuring adherence to controlled documentation and steady-state operation while maintaining ERP system audit trail review and user account maintenance.
- Participates in formalized processes related to system implementations to ensure appropriate controls are designed and in place both as part of the design and implementation process and in the resulting system process and functionality.
- Analyzes processes, risks, and controls related to ERP (NetSuite) to identify improvement opportunities, recommend actions that are pragmatic and achievable, and partner with management to resolve deficiencies.
- Establishes and maintains detailed process documentation and workflows to ensure proper understanding of NetSuite configuration, system interfaces and data flows.
- Supports NetSuite initiatives to improve internal control procedures, increase audit efficiencies, and drive process optimization focusing on system operations, change management, security and access rights, financial applications, and interfaces with external adjacent technologies.
- Supporting CMC\Tech Ops, Quality, Legal, Compliance, HR and Finance for ERP applications, data, reporting and associated business processes.
- Works with vendors in integrating IT, data, and processes into the ERP platform.
- Works with business and technology stakeholders to determine system roadmap priorities for associated business functions.
- Manages multiple high priority initiatives and executes in a highly technical and fast-paced support environment.
- Bachelor's degree in computer science, engineering, or similar STEM concentration. MBA\MS a plus.
- 8 years of application administration, development, design, configuration, release, validation, operations, governance, production, and support expertise within a complex pharma\biotechnology setting.
- Understanding and experience in rare disease space is an advantage.
- Oracle NetSuite administration certificate a plus.
- Prior hands-on experience with ERP Management, including oversight of Administration, Enhancements, and Operations.
- Proven NetSuite administrator-level knowledge of roles, permissions, custom objects, scripting, workflows, reports, and dashboards
- Adherence to corporate policies and procedures with a detailed understanding of SOX internal controls.
- Experience in Serialization process/chain of identity, DSCSA and 21CFR Part 11 compliance are mandatory.
- Experience in System Administration, Change Management, Data Integrity, and ALCOA+, SOPs and Documentation.
- Proficient with BI\Reporting solutions (. PowerBI, Tableau, Snowflake, Nitro)
- Ability to translate complex business problems into solutions.
- Business process design and documentation skills.
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Manager, Information Technology - Cranbury, United States - Rocket Pharmaceuticals
Description
Overview
Work at ROCKET PHARMA and help cure rare diseases
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary
The ERP Manager leads the administration, design, implementation, and support of ERP applications (NetSuite) throughout Finance and Accounting, CMC\Tech Ops, Quality, Procurement, IT and enabling functions. This is an IT technical role and will manage enterprise applications, maintenance, and delivery of IT ERP support enterprise wide. Functions include, but are not limited to accounting and finance, procurement, enterprise performance, warehouse and inventory, order management, integration, automation, business reporting and insights generation.
The Individual will maintain responsibility for the overall operational health of ERP Applications and boundary systems enterprise wide, policies in alignment with compliance and regulatory demands, and for inspection readiness (. SOX, 21 CFR Part11, HIPAA, GxP, GAMP-V, GDPR, DSCSA .
Responsible for all IT activities relating to the Quality, audit, validation and compliance of ERP processes, procedures, and systems in partnership with business leadership. Develops and participates in system audits, compliance programs, controls framework and guidelines.
Responsibilities
Qualifications
