Validation Software Facilitator

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