Associate Director, IT Site Lead & Mfg Systems
Bluebird Bio, Durham, North Carolina, United States
integrated product platforms with broad therapeutic potential
Associate Director - IT Site Lead, Business & Manufacturing Systems – bluebird Research Triangle
This key role is responsible for all IT operations in the Durham, NC (bRT) site providing both strategic as well as operational leadership for bluebird’s information technology systems. This includes oversight to IT Operations & Desktop Services, Application Support & Delivery, and Computer system validation process. The role will also serve as the business relationship partner to Pharmaceutical Sciences (Manufacturing, Engineering, Facilities, and Quality) teams located at the site ensuring alignment, governance and prioritization of IT initiatives.
About the role:
- Responsible for development, delivery and exceptional support of Information Technology Business & Manufacturing Systems solutions to support the strategic growth of bluebird bio’s Durham, NC site.
- Senior point of contact for delivery of departmental services both operational and strategic to the Durham site.
- As a member of the site leadership team (SLT), shares monthly performance through project reporting and key metrics to create awareness and highlight challenges and risks.
- Uses business relationship management and other site meetings to keep the business, bRT Site Head and IT Leadership Team informed.
- Leads, directs and motivates the bRT IT Department, ensuring that the structure, skills and competencies required adapt with business needs.
- Interprets business requirements, identifies & recommends opportunities for productivity improvements and implements where agreed.
- Develops and maintains lean and efficient ways of working, policies, guidelines and procedures for the department to ensure consistency and quality.
- Ensures that systems and solutions supported across the site are fit for purpose while seeking appropriate opportunities to improve.
- Prioritize, oversee, and manage portfolio of IT projects in support of strategic business goals. Ensure delivery of projects within determined time and budgetary constraints
- Provide operational support and drive improvements for IT systems, including ERP, at our first internal manufacturing site. Ensure plans are in place for business continuity for all IT systems.
- Develops strategic plans and budgets that meet the growth, scale and changing needs of the business
- Working with Quality Assurance Validation, use risk-based approaches to assess compliance impacts & build computer systems validation processes into system implementation & change control activities where appropriate
- Support and develop standard operating procedures for computer systems operating in a regulated environment ensuring 21 CFR Part 11 compliance.
- Bachelor’s or Master’s Degree in Computer Science, Information Systems, or other related field
- 8-12 years IT and business/industry work experience including extensive knowledge and expertise in project/program management, systems lifecycle management and enterprise application planning. 8-10 years of relevant IT management experience.
- Previous experience in the biotechnology / pharmaceutical industries and GMP Quality Systems. Experience with key business solutions such as Veeva, ERP, LIMS, MES, Rockwell Batch and SCADA solutions.
- Ability to influence across levels and functions, develop strategic plans and communicate strategy in a way that is easy to understand.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Effective risk analysis, prioritization and stakeholder facilitation to reach timely decisions.
- Experience with negotiating and managing vendor relationships and agreements, in particular with GMP, Laboratory solutions
- Strong management experience, supervising the work of both internal and external resources
- Strong project and portfolio management skills; Ability to oversee multiple projects, activities and tasks simultaneously
Strong Working Experience in developing and driving Computer System Validation program initiatives including GxP systems and ensuring CFR part 11 compliance.
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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