Solution Architect

Global system experience working with Regulatory Affairs Strategy, Intelligence, Regulatory Information Mgt & Operations, and/or Submission Publishing domains in support of market authorization.

Experience working with Clinical Operations team in the Quality space to manage Audits, Inspections, Vendor Oversight, and issues management such as SSNs. CAPA, and risk management.

Must have Veeva vault platform (Veeva RIM, Veeva Submissions, Archive, QMS, Quality Docs) experience.

Experience in Architecture Design for regulatory and quality Gxp and non Gxp IT systems.

Experience in leading system design as per Business requirement and add nonfunctional requirement as needed.

Recommend risk based solution to solve business needs based on policy.

Lead Solution reviews for the project and get it approved from review board.

Familiarity with Architecture Frameworks/Processes (e.g. TOGAF) and help define patterns and other architectural accelerators.

Experience in IT architecture, infrastructure, and cloud development.

Good problem solving, technical writing and verbal communication skills.

System experience managing architecture of complex cross-functional systems.

Understands system and data security.

Strong knowledge of SDLC methodologies.