Manager I, Project – 101102 – Quincy/Marina Bay
Manager I, Project - 101102 - Quincy/Marina Bay - 0300
Job Description: OPS Project Manager This position is a defined-term role Purpose/Role Statement Project Management: Lead validation/qualification project activities on a small to large scale related to software products, processes, standards and procedures. Create validation schedules, coordinate execution efforts with contractors, operators, engineers, and quality assurance staff members. Track and communicate progress of team work assignments against milestones. Software Validation: Manage/perform validation activities associated with the development, maintenance and retirement of software systems expected to meet regulatory requirements. Independently plan, perform and document validation activities (IQ, OQ, PQ) for software and equipment with software in a distribution / manufacturing environment. Collect and review validation data and generate deviation reports as needed. Change Control: Manage and improve existing change management processes and procedures. Act as change control manager providing guidance and review of all software / equipment changes. Facilitate oversight meetings / activities related to change review, acceptance, and policy reinforcement. Key Responsibility Project Management: Utilize project management skills and methodologies to manage and implement various projects related to software validation within the site. Establish plans, milestones and communicate status to upper level management. Manage small / medium size teams ensuring corporate policies and global regulations are followed. Manage cross-departmental teams driving completion of tasks. Work with international partners to ensure like-for-like implementations where possible. Provide strategy to upper level management while managing priorities and work-load. Software Validation: Demonstrate mastery of Boston Scientifics rigorous policies for automated software and device systems. Ensure systems are validated in accordance with the corporate and local policies and applicable FDA regulations. Lead the development and creation of software quality plans, validation plans, risk analyses, test protocols, test scripts and traceability analyses for retrospective and prospective validations. Lead and coordinate UAT and system testing activities including GUI, regression, black box, performance, back-end, stress and load testing. Participate in quality reviews. Participate and author business requirements, software design, functional specifications, and risk analysis including FMEArsquo;s. Change Control: Act as change control champion guiding departmental changes to software through established processes. Assure change control records are maintained and controlled through process and procedure. Perform review of documented requests for change to ensure the GMPrsquo;s and site level SOPrsquo;s are followed assuring accuracy of content. Maintain, review and verify the collection of system information including configuration, version, and installation qualification documents and software. Project Management: Drive/participate in CAPA investigation processes. Responsible for root cause determination, driving closure, and determining appropriate action based on analysis. Software Validation: Conduct process, software and equipment assessments to ensure compliance with FDA regulations assisting in/ authoring system intended use documents and following legacy software remediation policies and procedures. Change Control Track and manage all official change control documentation and software. Effectively communicate with the other departments within Boston Scientific, as well as with personnel at contractor sites, on possible change control and GMP deficiencies related to quality and compliance issues. Project Management: Attends and participates in management level project meetings and encourages cross-functional team relationships. Software Validation: Participate in peer reviews of requirements, design specifications, validation plans and test scripts. Act as a project team member who provides independent review on deliverables used to develop, implement and maintain Manufacturing/Device/Quality software in a validated environment. Change Control Prioritize change requests and perform risk/impact assessments. Write and/or review change control documentation including; specifications, protocols executed protocols, and help resolve deviations. Act as member of / facilitate the site change control board recording Minimum Education Required: Bachelor Expected Travel Time: None