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
Requirements Traceability Matrices
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