Change Control Project Manager (Contract)

Title/Role: Project Manager/Change Control

Area: Manufacturing Technical Operations (MTO)

GENERAL POSITION SUMMARY

The Change Control Project Manager is responsible for supporting the cross-functional project teams executing change controls. The Project Manager will track and report project scope/timeline/milestone status associated with cell and gene therapy Type 1 Diabetes team.

Must be detail-driven and have a proven history in managing and driving project success within the biotech industry. The individual requires a strong technical background solid working knowledge of GMPs understanding of the drug development pathway through commercialization and willingness to pivot as priorities change. Knowledge and/or experience with cell / gene therapy methodologies and a strong understanding of risk management will be an asset. Must have excellent communication skills written and verbal high attention to detail and the ability to work effectively in cross-functional matrixed teams.

RESPONSIBILITIES

• Partner closely with functional area leads maintain and actively monitor integrated 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 project team members to drive the completion of changes.
• Effectively communicate with internal team members and key stakeholders on the status objectives risks and mitigation plans associated with change control projects.
• Organize and maintain team communications including meeting agendas minutes tasks lists and risk analyses/mitigation strategies.
• Update and maintain project status tools such as a project action log and risk register.
• Develop and deliver project management tools and templates to manage change control 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.
• A minimum of 8 years of experience in the biopharmaceutical industry.
• A minimum of 6 years of experience in project management of biopharmaceutical product
• Working knowledge of biotechnology GMPs and drug development lifecycle.
• Ability to work effectively in cross-functional matrixed environment prioritizing and managing multiple tasks simultaneously integrating cross-functional issues and balancing competing priorities effectively.
• Expertise in Microsoft suite (Project PowerPoint SharePoint Word Excel Outlook). Experience with other PM tools a plus (e.g. Smartsheet Power BI etc.).
• Excellent oral and written communication skills including presentation and facilitation skills to effectively inform key updates & issues across all levels of the organization.
• Strong analytical problem solving and critical thinking skills including an ability to combine attention to detail with a big picture perspective.

• Strong understanding of regulatory requirements (FDA 21 CFR Part 211 EU GMP ICH Q10)

dependent upon experience

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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