Job DescriptionKey Duties & Responsibilities- Lead platform architecture, strategy and technical initiatives for Vertex Connects Portal (Salesforce-based Cell and Gene technology) for the CASGEVY and Type 1 Diabetes therapeutic areas.
- Understand system architecture and technical needs, create, analyze, and validate detailed architectural, functional and technical specifications, facilitate architecture and design sessions with cross functional and development teams to define and align on the solution, systems architecture, design, and other SLC/GxP deliverables.
- Leverage strong communication and analytical skills, technical expertise to understand, document, assess, and drive technical architecture/design needs to accelerate process enhancement and operational efficiencies.
- Providing input to strategic direction, contributing to the development of roadmaps to achieve the long-term and short-term capability needs of the Commercial and Supply Chain business groups.
- Achieve high stakeholder satisfaction and engagement levels across various levels of leadership within the organization.
- Participate in reviewing, planning, testing, and implementing regularly scheduled both internal and vendor releases/upgrades.
- Partner with offshore team members, functions, QA stakeholders, and IT peers for platform support, as well as enhancements and projects.
- Develop collaborative relationships with peers in IT, Quality, Vendor partners, and other teams to help design, develop, enhance, and deliver solutions that meet business goals and objectives.
- Manage the end-to-end lifecycle for regulated CGT platforms supporting both Commercial and Supply Chain business areas.
- Facilitate release management and production release schedule in coordination with cross-functional partners and other platform teams
- Lead platform communications (e.g. status reporting, downtime, releases) to all stakeholder groups
- Serve as Operations SME for enhancements, software upgrades, implementations, and integration projects, providing product and GxP expertise
- Responsible for risk and mitigation management to ensure high quality, on-time delivery
- Proactively champion, educate, and enhance delivery practices to introduce process efficiencies
- Define, manage and optimize DevOps framework / delivery operating model
- Manage CI/CD pipeline and software development capacity across teams
- Provide input into budget/forecasting estimates and resource allocation
- Coach and lead Vertex colleagues and onshore/offshore managed service providers
Required Education Level - Bachelor's degree in Computer Science, software engineering or other related technology degree
Required Experience - 5+ years of relevant work experience
- Functional/Technical knowledge in Cell and Gene Therapy, Patient portal, Chain of Identity, Capacity Planning, and related supply chain systems
- Experience in Sales Force platforms
- Experience in Patient and/or Product Scheduling
- Experience with Salesforce Agentforce and other AI automation tools
- Biotech or Pharmaceutical Industry Experience
- Experience working with SaaS solutions and vendors
- Experience handling GxP systems and security requirements including Disaster Recovery, Backup & Restore, Data Retention and Archival
- Experience with Part 11 CFR 21 GxP Validation
- Experience with stakeholder engagement, vendor management, and directing platform teams
- Some experience in four architecture specialization areas (business, information, infrastructure, software)
- Experience working within and leading in an AGILE team framework, across multiple business units and functions
Required Knowledge/Skills - Software vendor and MSP management expertise
- Executive-level communication skills; ability to explain complex topics in a digestible way
- Ability to drive continuous operational improvement
- Proven ability to stay abreast of industry and technology trends
- Expert knowledge in Agile SDLC, DevOps and GxP
- Functional and technical ability with configurations, customizations, and authoring SDLC documentation
- Demonstrated ability to interpret functional requirements and specifications to convert into technical or process-driven solutions and configurations.
- Experience in 21 CFR Part 11 requirements for GxP environments and the relevant SLDC requirements
- Exceptional analytical and problem-solving skills with attention to detail
- Flexibility to adapt to a continually changing and fast-paced business environment.
Other Requirements - Nice to have: Own Backup, Bartender and Salesforce Life Sciences Cloud experience
- Nice to have: Cell and Gene Therapy technology experience
LI-HYBRID
Pay Range:$170,400 - $255,600
Flex Designation:Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:In this Hybrid-Eligible role, you can choose to be designated as:
1.
Hybrid: work remotely up to two days per week;
or select2.
On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
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