R&D IT Manager
Full-time opportunity
Raleigh, NC
Hybrid - 3 days/week onsite
SMART IT People has an exciting full-time opportunity for an R&D IT Manager with an amazing company in Raleigh, NC. It has been ranked one of the top places to work.
Required skills:
- Bachelor's Degree in Computer Sciences/Information Systems or related discipline
- 5+ years of experience of Project Management and Computer Systems Validation
- Experience supporting a Life Sciences R&D organization
- R&D IT software applications (implement and maintain)
- Ability to work onsite in Raleigh 3 days/week
Desired skills:
- Experience supporting a medical device related organization
- Subject matter expertise in Clinical, Laboratory, Quality, Regulatory, and/or Safety disciplines
- PMP Certification or strong project management skills
Job description:
-Responsible for supporting the R&D organization from a technical and business process perspective.
- Duties include implementation of new R&D applications and projects, administration of existing applications and processes, and support of the business units in R&D.
- The ideal candidate will have a mix of technical and management skills that allow them to implement a software application from start to finish and maintain a strong solution-oriented relationship with business.
Computer Systems Validation (20%)
· Knowledge of Computer Systems Validation in a drug and medical device environment
· Knowledge of EU, ICH, FDA guidelines and GAMP 5 principles
· Ability to create Validation Plans, Requirements, Test scripts and other Validation deliverables
· Experience with CSA and ALM tools is preferred
Project Management (40%)
· Lead and facilitate meetings, interact with vendors and internal R&D business units and build strong relationships
· Act as an advisor to the business and guide the strategic direction of the R&D IT application landscape
· Manage vendors which may include licensing, budgeting, service level agreements, etc.
System Administration/Ownership (40%)
· Implement software applications from start to finish and maintain the applications in a compliant state
· Prioritize and resolve issues, suggest solutions and implement changes.
· Gather requirements, document and operationalize complex processes
To apply, please send your resume in MS Word format to: alice@smart-itpeople.com with job title in subject line.
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