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Associate Director, IT Business Partner, Manufacturing and Quality - Cambridge, United States - Editas Medicine
Description
Key Responsibilities & Accountabilities:
This role is a liaison between IT and stakeholders in Manufacturing and Quality, serve as a strategic partner with business function groups, advocate and lead IT business needs and portfolio management.
This role will collaborate/consult with stakeholders/business groups on a regular basis to ensure that IT is aware of the functions' strategy and goals in order to identify new or enhanced capabilities and plan relevant investments in technology solutions and services.
This role will ensure that stakeholders are consulted about changes to IT processes and services, and that specific requirements are taken in to account when new or changes to IT services/underlying infrastructure are being planned.
The role will also ensure that interoperability, architectural and security standards, and responsiveness levels are defined according to both IT and stakeholder group requirements Establish and develop strong relationships with function leaders and stakeholders to understand strategy needs and execution plans Lead the development of multi-year function-specific strategies and roadmaps with business groups Contribute to the annual LRP and budget process for client groups and verify that the company is maximizing its investments in systems and business processes Remain up to date on emerging and innovative technologies which may enable or disrupt business capabilities, and provide counsel to stakeholders when developing strategy & roadmaps Lead development of annual portfolio and budget recommendation for client groups Lead creation of business cases, and ensure appropriate communication and reporting on project progress Lead implementation for large programs in partnership with sponsors and stakeholder groups Provide project management for new systems and services related to the functional and technical requirements in client groups, in accordance with the IT project lifecycle framework Coach and mentor IT/business PMs in successful delivery of projects Oversee related implementations in conjunction with the IT Infrastructure team to ensure proper security, efficient utilization, capacity and user access Establish Partner/Vendor management strategy to elevate vendor/partner performance and value Manage the development of statements of work, contracts, managed service and service level agreements with vendors, and strategic sourcing related to the area of focus Ensure that the application architectures are understood, properly implemented, and administered effectively Establish, manage, optimize application support model for all portfolio applications Continuously review current and planned application landscape for opportunities to improve process efficiency/drive new insights/rationalize Ensure SOX and GxP compliance of the client groups' app portfolio Establish performance metrics for the business groups portfolios Maximize exploitation of current technology capabilities, providing training and process improvement reviews Stay abreast of IT best practices around pharmaceutical and other industry technologies and their relevance to Editas Assist in the writing and management of controlled processes around systems including validation, change control, electronic signature, and system-specific sysadmin documentation Develop and disseminate application training materials and support standards for the relevant user community Develop and test disaster recovery and business continuity plans Requirements Knowledge, Skills & Capabilities: Extensive experience of building and maintaining business partner relationships, strategy planning and roadmap building & execution Extensive experience of manufacturing business processes and practices, including lab and manufacturing good business practice principles Proven track record of administering GxP systems and thinking holistically about the business processes critical to company success across multiple systems and departments Third party vendor/partner and contract management: experience managing vendors/partners effectively to achieve business goals while maintaining project timelines and budget Project management, portfolio management: experience establishing appropriate governance, managing application, integration, and reporting projects throughout the entire project lifecycle including requirements gathering and documentation, vendor selection, implementation tracking, risk/issue management, change management as well as system documentation, release, and training Experience as a business analyst, including identification of non-technical business requirements, translating specifications into solution designs, ensuring quality and successful testing, financial and resource management Excellent knowledge of 21 CFR Part 11 compliance and Computer System Validation (CSV)Ability to multi-task and meet deadlines in a fast-paced, changing environment. Self-starter, hands-on attitude and out-of-the-box thinking. Proven analytical thinking and problem-solving capability Extensive experience with key systems in business domain, including but not limited to Veeva quality Docs, QMS, BMRAM, QC LIMS, Oracle Supply Chain Management 5-8 years experience in a public, commercial-stage company in the pharmaceutical or biotech industry Education & Relevant Work Experience:
Bachelor's Degree 10+ years business partnership/system implementation/project management/application support experience 5-8 years experience in a public, commercial-stage company in the pharmaceutical or biotech industry Physical &
Travel Requirements:
As necessary to facilities laboratory space in Devens MA, and Editas facilities in Boulder ColoradoBenefits
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply.
Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
