Develop, create, and implement IT processes and policies as it relates to Change Management/Control, Compliance, Governance, and Vendor Management.
Analyze and determine the appropriate course of action for non-compliance/conformance deviations
**Key Responsibilities**:
- Leads and provides guidance in developing, creating, and implementing IT processes and policies as it relates to Change Management/Control, Compliance, Governance, and Vendor Management.
Key SME with extensive knowledge and responsibilities for the activities within the full life cycle of the designated IT processes such as:
- Negotiates and interprets change request to IT systems to ensure they are managed in a controlled manner and determine and follow up on any additional technical information that may be needed.
- Acts as the main point of contact for IT employees on IT Policies and controlled internal IT Procedures.
Collaborates with auditors and IT technical SMEs to comply with internal and external audit requirements (e.g, SOX compliance)
- Develops and creates internal and external processes for IT Governance (e.g., system and data access)
- Collaborates with IT stakeholders to negotiate and establish vendor contracts and service level agreements.
- Advises and trains IT employees, in group and one-on-one training sessions, on navigating the Change Management module of the Service Desk System as well as the Change Management process
- Collaborates with Corporate SWQA team to ensure validation requirements are met throughout the Change Management life cycle
- Leads the weekly Change Control Board Meeting in collaboration with team members
- Responsible for Tracking and Reporting of IT Root Cause Analysis
- Ensures ticket is opened and filled out completely for every system outage and/or other known and unresolved systems issues, following up with the responsible IT employees as needed.
- Coordinates the monthly root cause analysis meeting by scheduling the meeting; determining the required attendees and ensuring that they are all invited; preparing and distributing the meeting agenda; taking notes, including capturing action items during the meeting; preparing and distributing the meeting minutes after each meeting.
- Compiles and consolidates data for recurring and ad-hoc management reporting and metrics
- Identifies opportunities for process improvements.
Other duties as assigned by Leadership.
**Education and Experience**:
Bachelor's degree in computer science, Business, or related discipline Experience working in a FDA regulated environment Preferred.
8 years of experience Related Required
**Additional Skills**:
- Intellectual Skills: Excellent analytical, detail-oriented, organized and information seeking skills
- Interpersonal Skills: Adaptable, collaborative, ethical, persistent, effectively manages stress and a team player.
- Ability to manage competing priorities in a fast-paced environment
- Must possess excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Extensive documentation and trouble-shooting skills
- Ability to learn new technologies in a rapidly changing environment
- Must be able to establish and maintain effective working relationships
- Ability to use Microsoft Excel, PowerPoint and Word
- Experience working in a FDA regulated environment preferred
- Excellent analytical, detail-oriented, organized and information seeking skills
- Excellent organization and time management skills
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.
Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 18,500 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work.
From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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