The newly formed IBM Watson Health business unit is now looking for talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity. The convergence of data and technology is transforming healthcare and life sciences organizations in every way. New roles are being created that never existed before to meet the demands of this transformation.We have an exciting opportunity for a Project Manager / Project Leader within the Verification and Validation department (FDA, MDD, HIPAA, GxP) of Watson Health. As a Project Manager / Project Leader specializing in Healthcare industry you will support Global Watson Health solution teams with developing and delivering validated tools, compliant platforms and solutions. You will work with and drive globally resourced team(s) on small, medium and large complex V&V projects. Work according to plans developed by the Verification and Validation management lead or translates those portions of requirements they are responsible for into plans to culminate in acceptance of results while meeting business objectives. The essential functions of this role will consist of the following:
Work collaboratively with project stakeholders to develop a comprehensive project plan based on approved funding. Project plans will include: Scope, Schedule, Cost, Quality, Organization and Communications, Staffing, Risk and Issue Management, Test, Configuration, and Change Management.
Perform Project Planning. Create / build / update project schedules, project charters, project plans, status reports, and work breakdown structures.
Lead teams performing Computer Software Validation (CSV) Test / Protocol execution and IQ, OQ, PQ of Regulatory tools and assets system, design, logic/ workflow and documentations that complies with cGMP, GxP-FDA compliance regulated computerized system
Lead V&V teams in the execution of approved test scripts to validate Test Results conforms with Design, FRS, URS, SOPs, Traceability Matrix in compliance with cGMP and GDP requirements.
Ensure that the Test Results conforms with Design, FRS, URS, SOPs, Traceability Matrix in compliance with cGMP and GDP requirements.
Perform Project Scope Management. Effectively manage project work within the stated scope.
Complaints Investigation for Medical Device (CAPA)
Familiarity with in FDA Regulations and audits – GMP, CGMP, GAMP, GXP, QSI, 21 CFR Part 11 and CFR Part 820, ISO 14971, Risk Assessment for Medical Device, ISO 1345, IEC 62304 – International Standards (Europe and US) and IEEE, SEI, Six Sigma and other ISO standards and regulations.
Perform Quality Management. Manage assigned projects and subprojects / work efforts using appropriate rigor.
Perform Project Cost/Sizing Management to manage Estimated Time to Complete tasks (ETCs).
Perform Issue & Risk Management. Create RAID logs (Risk, Action, Issue, and Decision).
Perform Communication Management. Create / implement project organization and communication plans which enable the project team to effectively work together to meet project objectives.
Perform Meeting Management. Prepare meeting agendas and meeting minutes, distribute meeting documentation, and maintain and monitor action item listings as necessary. Facilitate and lead meetings and steering committee meetings by being well-prepared and adhering to topics.
Maintain complete confidentiality of company business.
Successful candidates will possess the following key attributes:Knowledge of the PMI Process Groups; Initiating, planning, executing, controlling, and closing. Knowledge of current Project Management methodologies. Engaged as a professional who advises others and works with team members to articulate, compare, and drive complex projects to closure using approaches based upon project management principles. Team members might include client, supplier and IBM staff. Recognizes and articulates complex problems related to the project / segment of the project or function. The following are requirements for the role of Project Manager / Project Lead:
BSEE/BSCS or equivalent Technical Degree
Must have demonstrated success as a project manager and/or project lead.
Knowledge of FDA regulations required to test medical products
21 CFR Part 11 experience
Strong knowledge of validating products based on SaaS, cloud-based technologies
Expertise in quality reviews
Work effectively on multiple projects, to set priorities and maintain schedules.
Cope with stressors and demands that are associated with the job, the work environment and the projects so that acceptable and defined levels of performance and overall contribution are maintained.
Work in areas which adhere to Watson Health regulatory standards, or where no such standards exist, to accepted guidelines.
Desirable Technical Skills:
Cloud, Virtualization, KVM, VMWare
Integration test frameworks such as Cucumber, Selenium
Application server middleware (e.g. WebSphere Liberty, Oracle WebLogic)
Databases (relational and other; DB2, Cloudant, etc.)
Knowledge of scripting and integration test frameworks
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At least 5 years work experience as a Project Management Professional.