This is a key position within the Geron IT organization. This position will be responsible for the planning, management, implementation, and support of systems for Geron's R&D and G&A departments. This position will serve as an IT liaison to various Business groups and will translate and validate their business requirements into solution requirements to meet the business needs.
This role is a Hands-on Platform/Tech Lead across multiple initiatives, driving business requirements gathering sessions, focusing on delivering current-state system improvements and future-state requirements, and evaluating/implementing technical solutions contributing to the Enterprise Applications portfolio. This role will be responsible for IT System Ownership for identified platforms/systems. This position will collaborate closely with IT peers, cross-functional teams, and IT Vendors and will also manage the future FTEs and FTCs. This role will ensure investments are aligned with Geron's corporate objectives and are designed to maximize utility across Geron's business functions. This role will provide leadership in maturing Geron's project Management Framework including SDLC improvements and introduction of Agile methodologies, in addition to system delivery/implementation.
Essential Duties and Responsibilities
- Facilitates business requirements gathering and verifies that requirements are clear and concise for business, IT and Vendor delivery teams.
- Participates in business process design/ configuration workshops and provides necessary technical consultation/assistance to Business SMEs.
- Develop/ manage the Project management lifecycle documentation: Business case, Project Charter, SOW, Project plans (WBS), scope, budget, and resource plans.
- Lead and monitor the planning, configuration, deployment, and support of Geron’s systems.
- Leads and manages the internal and external project teams (FTC, Vendors), with key focus on delivery and provided weekly project status/dashboards to Executive leadership.
- Develops system selection requirements, participates in product evaluations (RFP/RFI, Cost Analysis), driving decision making on product/vendor selection and fosters vendor partnerships.
- Focuses on the Business Relationship Management (BRM) by establishing positive relationships with key Business SMEs/stakeholders.
- Develops/assists in Validation/system documentation e.g. URS, FRS, Val Plans, Test plans and administrative SOP’s/WI’s.
- Develops operational manuals/runbooks to support the operations and for knowledge sharing and cross-training.
- Responsible for user administration, operational support ensuring Geron applications are meeting the compliance/regulatory standards (GxP, SOX).
- Notifies Business and IT Management on all process and system changes including vendor releases, new features, bug fixes, coordinates implementation of the enhancements and provides appropriate end-user training (if needed).
- Supports Helpdesk requests/tickets, responds to critical issues during off hours when necessary and acts as a backup for other IT SME’s as required. (NJ location: This role will be required to visit office to setup /support any periodic company events. CA location: This role will be required to support Global users (NJ office) with ticket requests (starting 6am PST)
- Responsible for partnering with QA for timely closure of exception reports, CAPAs and Deviations, periodic reviews of ACL and SOP’s.
- Performs complex diagnosis of problems and documents/reports the impact and root causes.
- Represents as System Owner in the event of Regulatory Audits and Inspections (Internal and External).
- Contributes to the Project Management standards, processes, and builds capabilities to develop a stronger portfolio.
- Stays current with technological developments in various domains (R&D, G&A), including reading technical articles, and attending conferences and workshops.
- This role will assist in team’s workload and will take on other duties as assigned.
minimum qualifications and requirements
- A minimum of a Bachelors’ degree in Computer Science, Information Technology, or related discipline is required. An advanced degree is desirable.
- A minimum of 10 years practical work experience within Life Sciences domain with knowledge of Clinical, Regulatory, PV, Quality, G&A processes/procedures, including implementing and supporting those systems. A minimum of 6 years of management and Enterprise project implementation experience supporting business critical systems.
- Need to have relevant experience in any Veeva Development Cloud/Vault platform, SAS, ERP, and ITSM.
- Ability to articulate technical problems and business value to a wide business audience. Experience working in a cross functional setting (Business Owners, QA, IT, end users) with differing levels of technical expertise.
- Detail oriented, Hands-on lead driving successful delivery of projects ensuring positive customer satisfaction and passionate about system implementation, delivery, maintenance, and end user support.
- Must possess and demonstrate strong leadership, organizational skills, positive team culture and agile mindset.
- Strong knowledge of procedures/ best practices related to FDA Regulations, EU GMP Annex 11, 21 CFR Part 11, CSV, GAMP 5, cGxP, SOX/ITGC required. Familiar with Waterfall, and Agile SDLC experience in a regulated environment.
- Must be able to demonstrate strong analytical and problem-solving capabilities.
- Ability to troubleshoot tickets/issues and work independently with minimal supervision.
- Familiar with relational databases and reporting tools, experience in SQL is desirable.
- Must demonstrate Geron Values (Authenticity, Accountability, Excellence, Integrity, Respect).
- Excellent oral and written communication skills are required.
- Proactive, self-motivated with high degree of initiative and excellent follow-up skills.