This Quality Project Manager will be responsible for supporting cross-functional project teams executing Quality strategies within multiple programs. This individual will work with the Quality leads and interface directly with internal cross-functional teams. This individual will track, report, and project scope/timeline/milestone status associated with qualities projects, Team meetings and external meetings.

This position is to drive plant implementation for the ISO 13485 and EU MDR regulatory requirements (European Medical Device Regulation. Must be able to effectively plan/track, collaborate, and manage the actions of different functions to deliver compliance to these regulations by the required deadlines.

Responsibilities:

• Identify gaps against ISO 13485 and EU MDR requirements and lead on working on remediation of the gaps.
• Work closely with area leads to develop and maintain integrated dashboards/ project plans.
• Identify/communicate interdependencies as well as critical path activities for the project(s).
• Track and monitor key milestones and decision points and work with team members to meet commitments and drive delivery of objectives.
• Be the central source of information for the project(s)
• Effectively communicate with team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects.
• Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, risk analyses/mitigation strategies, and other relevant materials using preferred technologies to support the project(s) teams.
• Update and maintain project status tools, such as a project action log, risk register, and dashboards.
• Assist in the creation and deployment of templates to manage team activities.
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.

Qualifications:

• Bachelors degree in engineering, life sciences or related field. Advanced degree (MS, or MBA) and/or PMP Certification preferred.?
• A minimum of 6 years of experience in the biopharmaceutical or medical device industry.
• Previous experience of a minimum of 5 years in Quality/Manufacturing/Product Development or EU Medical Device Regulation (MDR) or CE Marking is required.?
• A minimum of 3 years of experience in project management of pharmaceutical or medical devices is required
• Experience interacting with Senior Management
• Working knowledge of cGMPs, and device development lifecycle.
• Ability to work effectively in a cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
• Experience independently developing complex project timelines, define project scope, convey timeline visuals (Gantt Charts)
• Ability to connect enterprise level strategy to project level objectives and clearly communicate and lead project deliverable to meet enterprise objectives and remove roadblocks.
• Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook, Teams, OneNote, Visio, PowerBI). Experience with other PM tools a plus (e.g., Think-Cell, OnePager, Office Timeline, etc.).
• Candidates should possess individual and project organization skills, strong written and verbal communication skills, strong sense of urgency and accountability, ability to respond quickly to requests and efficiently follow up and drive project action completion, should thrive in a faced paced organization and comfortable managing high visibility projects.

$73-$85/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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