Business Systems Analyst - validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD & ISO 13485, Data Privacy Direct end client Hybrid model

Your specific responsibilities will include:

• Concurrently manage multiple projects of diverse scope across functional areas
• Manage and deliver projects using agile and waterfall methodologies
• Manage project budgets, scheduling, planning and contractor resource assignment and track vendor and consultant performance including billing against budget and contract
• Collaborate with Product Managers, Architects, Engineers, Developers, and User Experience Designers on scope, solutions, constraints, and risks.
• Manage compliance documentation processes and systems for department and business partners
• Characterize for compliance purposes as-built and vendor provided business solutions that may involve automated systems and/or modifications to business processes.
• Provide expertise in documenting the deployment of systems and/or processes.
• Perform a key role – as part of a project team in delivery of solutions that are cost effective, sustainable, and meet business requirements.
• Be accountable for documentation, which may include, but is not limited to:
• System Risk Assessments
• Data Classification Reports
• User Requirements
• Validation Plans
• Validation Reports
• Validation Registries
• Requirements Traceability Matrices
• Test Plans
• Test Reports
• Functional and/or technical specifications
• Data and process flow diagrams
• Training documentation and/or work instructions
• Other Computer System Validation documents and related systems
• Depending on the application configure system settings and/or options.
• Provide consultation to customers regarding enhancement/improvement of current solutions and implementation of new solutions – both systems and processes.
• Facilitate and/or support customers in UAT planning and execution.
• Participate in and advise roadmap discussions; be a key member of vendor assessment teams.
• Drive resolution of business or systems issues.
• Be a trusted partner for the Global Privacy Office, IT Security, and Business Quality teams
• Maintain an expert-level knowledge of the dynamic health authority governance; inclusive of GDPR, CCPA, HIPAA, SaMD, 21 CFR part 11, Article 11.

• BA or BS in life science, informatics, business, or equivalent. MA or MS and post-graduate coursework are desirable.
• At least 10 years of related experience, domain knowledge of the pharmaceutical industry and manufacturing/quality assurance processes and systems, computer systems validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD & ISO 13485, Data Privacy
• Experience and understanding of application development methodology - including Agile and Waterfall approaches, functional requirements, process modeling and re-engineering, use case development, user acceptance testing, organizational change management, and large-scale system implementations.
• Excellent written and verbal communication skills; able to quickly produce clearly written, well-organized documentation; excellent presentation and meeting facilitation skills.
• Proven skills in relationship building, customer-focus, decision-making, and problem solving.
• Demonstrated ability to quickly learn the business in unfamiliar areas.
• Experience with and understanding of any of the following areas a plus:
• Pharmaceutical/Biotech Good Clinical Practice (Google Cloud Platform) environment
• Business processes around financial controls and portfolio management of large scale engineering capital projects
• Computer systems validation