R&D IT Manager

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.