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IT Applications Manager
2 months ago
Manager, Information Technology - ERP Architecture and Administration
Compensation: $142,000 - $164,000 plus bonus, healthcare, 401k
Barrington James is collaborating with a fully integrated, clinical-stage pharmaceutical organization that is pioneering gene therapies aimed at addressing multiple rare childhood diseases.
We seek proactive team members who thrive in collaborative environments. Our mission is to discover gene therapy solutions for critical health challenges and positively impact patient lives. This role presents a unique opportunity to become a vital part of a small, dynamic team within a scientifically driven company recognized as a leading innovator in biotechnology.
Position Overview
The ERP Manager is responsible for the administration, design, implementation, and support of ERP applications (NetSuite) across various departments including Finance and Accounting, CMC/Tech Ops, Quality, Procurement, IT, and other enabling functions. This role is technical in nature and encompasses the management of enterprise applications, maintenance, and delivery of IT ERP support throughout the organization. Key functions include accounting and finance, procurement, enterprise performance, inventory management, order processing, integration, automation, and business reporting.
The individual will oversee the operational integrity of ERP applications and associated systems across the enterprise, ensuring compliance with regulatory requirements and readiness for inspections (e.g., SOX, 21 CFR Part 11, HIPAA, GxP, GAMP-V, GDPR, DSCSA, etc.).
Additionally, this role entails managing all IT activities related to Quality, audit, validation, and compliance of ERP processes, procedures, and systems in collaboration with business leadership. Responsibilities include developing and participating in system audits, compliance programs, and establishing a controls framework.
Key Responsibilities
- Ensure compliance with ERP functional and application architecture, maintaining required service levels and adherence to policies and procedures for regulatory compliance including GxP, GDPR, CSV, HIPAA, and SOX.
- Manage GxP change management, release management, and validation of configuration changes across multiple environments, ensuring controlled documentation and operational stability while maintaining ERP system audit trails and user account management.
- Engage in formalized processes for system implementations to ensure appropriate controls are designed and integrated into both the design and implementation phases.
- Evaluate processes, risks, and controls related to ERP (NetSuite) to identify opportunities for improvement, recommend feasible actions, and collaborate with management to address deficiencies.
- Establish and maintain comprehensive process documentation and workflows to ensure clarity on NetSuite configuration, system interfaces, and data flows.
- Support NetSuite initiatives aimed at enhancing internal control procedures, improving audit efficiencies, and driving process optimization across system operations, change management, security, access rights, financial applications, and integration with external technologies.
- Provide support to CMC/Tech Ops, Quality, Legal, Compliance, HR, and Finance regarding ERP applications, data, reporting, and related business processes.
- Collaborate with vendors to integrate IT, data, and processes into the ERP platform.
- Work with business and technology stakeholders to establish system roadmap priorities for relevant business functions.
- Manage multiple high-priority initiatives and execute them in a fast-paced, technical support environment.
Qualifications
- Bachelor's degree in computer science, engineering, or a related STEM field. An MBA or MS is a plus.
- 8 years of experience in application administration, development, design, configuration, release, validation, operations, governance, production, and support within a complex pharmaceutical or biotechnology setting.
- Familiarity with the rare disease sector is advantageous.
- Oracle NetSuite administration certification is a plus.
- Hands-on experience with ERP management, including oversight of administration, enhancements, and operations.
- Proven knowledge of NetSuite at an administrator level, including roles, permissions, custom objects, scripting, workflows, reports, and dashboards.
- Strong understanding of corporate policies and procedures, particularly regarding SOX internal controls.
- Experience with Serialization processes, chain of identity, DSCSA, and 21 CFR Part 11 compliance is mandatory.
- Expertise in System Administration, Change Management, Data Integrity, and ALCOA+, as well as SOPs and Documentation.
- Proficient in BI/Reporting solutions (e.g., PowerBI, Tableau, Snowflake, Nitro).
- Ability to translate complex business challenges into effective solutions.
- Strong skills in business process design and documentation.
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