Validation Software Facilitator

Illinois

‐ Onsite

This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Training Compliance Audit Support Quality Assurance Coordination Project Management Administration SaaS SLC

Summary

Provide Software Quality Assurance services for regulated/non-regulated computerized systems assuring computerized systems adhere to quality standards and applicable regulations throughout the system's life cycle.
Compliance function for the Computerized System Life Cycle (SLC), supporting IT systems owned by Operations, Commercial and International Headquarters

Specific tasks include

Validation Master Planning for IT Systems
SLC Review board sponsorship
SLC deliverable review and approval
Requirements/traceability verification
Certification Summaries
IT System Production Incident Reports
IT System Exception Report support
Policy/procedural changes and approvals, as appropriate
Audit/inspection support
Periodic reviews
IT Supplier/Service Provider Evaluation review and approval
Operations SQA Library Administration
Corporate/Divisional Compliance Plan implementation and support
Be a subject matter expert in Software Quality Assurance processes, specifically with respect to Care Models
Be empowered to guide and make recommendations to the Brands for projects that may be unique in nature
Serves as a strong liaison and coordinator between SQA, IT and Brand Teams for SQA activities
Have a working knowledge of ePASS Promotional Projects process
Provide step-by-step guidance, mentorship and training to Brand IT and Business teams to successfully complete SQA related processes

SKILLS:

Qualifications

Have a thorough understanding of company systems
Communicate closely with Brand Stakeholders including weekly status reports and assist in project activities where needed
Have strong knowledge of FDA, HIPAA and HITECH guidelines related to SQA processes, specifically as we work with external SaaS vendors
Have at least 2 years of project management/coordination experience
Preferably possess BioPharma IT and Health IT experience as we may work on integrating datasets from Health Systems, HCPs, Pharmacies, Labs etc.
Keep up to date with relevant industry knowledge, trends, technologies and federal/state regulations
Participate in Process Improvement and Pilot initiatives related to Care Model Ecosystems and Promotional Multimedia

To apply to this project you must log in.