Job Description:
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 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.
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)
- Understanding of risk assessment.
