Business Process Architect
Core
Analyze and design new business processes and create documentation to guide implementation of new processes and technologies in a GxP environment.
Role type
Senior Business Process Architect (Compliance/Validation)
Builds
Comprehensive validation documentation, SOPs, and process workflows for regulated projects
Domain
Pharmaceutical regulatory compliance and Computer System Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
End-to-End CSV in GxP environment, V-Model lifecycle, Pharma Regulatory Compliance, FDA/EMEA guidelines, CFR Part 11, GAMP5, SOP/Work Instruction writing, Process mapping, Analytical skills
Preferred skills
External audit support experience, Project management methodologies
Technologies
V-Model, GxP, FDA, EMEA, CFR Part 11, GAMP5
Responsibilities
Lead teams and perform project validation activities, Develop and maintain comprehensive documentation of business processes and workflows, Represent the compliance/validation team in internal and client meetings, Provide coaching to teams to ensure adherence to client processes and validation objectives, Facilitate workshops to gather requirements and feedback from stakeholders, Understand and apply FDA and other regulatory guidelines
Seniority
Senior, hands-on IC with team leadership