Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and
decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position: The Director of Quality and RegulatoryBusiness Systems will be responsible for leading a team focused on the processarchitecture, business analysis, business requirements mapping, projectmanagement, and change management of key electronic quality management systems(eQMS) and regulatory information management (RIM) systems. The Director of Quality and Regulatory Business Systems will work with cross-functional businessteams to help ensure compliance to systems implementation and Quality Systemrequirements. Providing leadership in development of processes, which defineenterprise system requirements. Theideal candidate will have electronic business system implementation, planningand execution experience, regulatory and/or quality systems experienceimplementing eQMS systems; have the ability to work with executive stakeholdersthroughout the organization; and have in-depth experience in business changeinitiatives. This individual will be able to understand the currentcomplexities of the organization's regulatory information management processesand how those processes flow through current technology and then buildfuture-state business process models to best realize the organization's growthstrategy.
This is a business leadership role and not an IT /Solution role.
Rolesand Responsibilities:
Work with business technology and quality systems stakeholders-bothleadership and subject matter experts-to build a holistic, technology agnosticview of the organization's electronic quality management system (eQMS), businessoperations systems, and regulatory information management business processes.
Closely partner with IT to make sure that business and ITstrategies remain in constant alignment.
Closely partner with regulatory, quality systems, andproduct quality leaders to understand current and future business initiatives.
Lead a team in the creation of business processblueprints for how our processes flow into and out of our technology solutionsfor eQMS and RIM systems
Lead a team that maintains eQMS installation andconfiguration management procedures, and support issues proactively to providetimely updates and resolutions to end users.
Lead a team that develops and reviews protocols, plans,scripts, reports, SOPs etc. associated with the implementation and maintenanceof computerized systems
Represent business systems at cross-functional meetings
Lead a team of business analysis, who are proficient inauthoring documents related to management of computer software systems and applications',configuration management, business analysts, change management experts, anduser requirements writers.
Develop deliverables that are valuable to the business,including business capability mapping, 3-5 year change roadmaps, businessrequirements documents, and process change workflows.
Working knowledge of business best practices around eQMSand RIM.
Collaborate with solutions team (IT) to leveragetechnology to enable the organization's future-state business capabilities.
Provide insights to and gain buy-in from key internalstakeholders including but not limited to Regulatory, Quality, Compliance, SupplyChain, Labeling, Marketing, and Product Development.
Operatebusiness model analysis of current systems and identify gaps in process streams
Ensuresustaining business needs are met as well as alignment with future systemcapability needs
Createsynergies with global business entities to ensure alignment for needs andgrowth requirements are met
Prepareand complete action plans to implement productivity, quality, problem resolving,identifying trends, determine system improvements, and implement change
Skill/Job Requirements
Education:
B.S. or higher in Science, Technology, Engineering, or related field preferred
Non-technical degree with equivalent complex experience acceptable
Experience/Skills:
Minimum 7+ years of people leadership experience
Minimum 7+ years relevant experience working in a regulated environment
Experience with Document Management Systems, Trackwise and Regulatory Information Management Systems
Working knowledge of FDA , ISO and EU regulatory requirements required
Previous experience in implementing or administration of an eQMS or RIM software system is required
Proven track record of developing people and growing a department
Experience working with business software systems, writing product requirements required
Strong Project Management Experience with proven success
Experience building multi-year improvement roadmaps
Ability for big picture thinking but also capable of task-oriented execution
Ability to synthesize data and observations to see trends,
Partner with Quality to identify gaps against regulations and make define action plans
Independent thinker, willing to present alternative conclusions or inferences
Ability to understand detailed technical information such IT requirements
Ability to influence others cross organizationally at various levels
Experience in continuous improvement methodologies such as Lean Six Sigma
Strong verbal and written communication skills, proven ability to translate analytical and technical information into effective presentations for business consumption
Good interpersonal skills and able to work well with cross-functional teams
Solid attention to detail, organization skills and extensive ability to multi-task and project manage across multiple projects/activities in a team setting
We are an AA/EEO/Veterans/Disabled employer. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
