Job Description
Job Description 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 T1D 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.
*** Change control experience and project management experience is required. This is an active role, candidate will be responsible for owning/writing change controls and manage them from start to finish. ***
The role manages 30-35 Change Controls in various stages of implementation, the ability to handle that much work is a necessity. 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
- Bachelor's 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)
Pay Range $65-$69/hr Requisition Disclaimer 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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Job Tags
Contract work, Temporary work,