Validation Manager(Hybrid) Location:Raleigh, North Carolina

Validation Manager(Hybrid)
Location:Raleigh, North Carolina
Interview:Phone+Skype

The Validation Manager, R&D IT is responsible for implementing a computer software assurance strategy for the R&D IT department. This includes reviewing and revising the existing processes and procedures, implementing an ALM tool and ensuring its successful adoption within R&D, and developing validation templates.
A successful candidate will have recent CSA experience, an understanding of the regulatory landscape, and familiarity with validating SaaS applications, laboratory instruments and applications, and AI models.

1 Validation Strategy
Subject matter expertise with GAMP 5 principles, US Code of Federal Regulations, and EU Annex 11 regulations
Subject matter expertise in computer software assurance principles
Ability to review processes and procedures and implement a comprehensive and compliant computer software assurance strategy
Ability to lead and facilitate meetings, interact with relevant stakeholders, and build strong relationships
This activity constitutes ~10% of the job description

2 Technical Writing
Ability to write technical documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and informal training documentation
Ability to write Validation Templates in accordance with Standard Operating Procedures and relevant Regulatory guidelines
Ability to write validation documents to support the implementation of software applications
This activity constitutes ~30% of the job description

3 System Implementation
Ability to implement a GxP SaaS based electronic validation application, including project management and all relevant validation documentation
Ability to drive adoption of the new application in accordance with the policies and procedures
Validation support for other projects and applications in accordance with policies and procedures
This activity constitutes ~60% of the job description

Technical & Functional Skills
Experience with Computer System Validation, Computer Software Assurance and GxP relevant applications
Experience with writing standard operating procedures, validation templates, validation deliverables
Experience running projects and strategy initiatives
Minimum Qualifications
Bachelor's Degree in Computer Science / Information Systems or related discipline
5 7 years of experience in a position of equal scope and responsibility
Experience in the pharmaceutical or medical device industry
Preferred Qualifications
Recent experience with CSA and ALM implementation
Experience with CSA of SaaS applications
Experience with CSA of laboratory instruments, IPCs, and applications
Experience with CSA or CSV of AI models
Travel Requirements
At least 3 days in office
Physical Requirements
This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.

Himanshu Goswami

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom