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Aviation Jobs in Boston, MA

Change Control Project Manager

Katalyst Healthcares & Life Sciences
  • Boston, MA
  • Instant Apply
30+ days ago

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.

Roles and 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

Education and experience :
  • 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.

Numbers & Facts

LocationBoston, MA

Skills

  • Analysis Skillsunmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Change Managementunmatched
  • Code of Federal Regulationsunmatched
  • Communication Skillsunmatched
  • Cross-Functionalunmatched
  • Detail Orientedunmatched
  • Drug Developmentunmatched
  • Establish Prioritiesunmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Gene Therapyunmatched
  • GxPunmatched
  • ICH Regulationsunmatched
  • Meeting Minutesunmatched
  • Microsoft Excelunmatched
  • Microsoft Outlookunmatched
  • Microsoft PowerPointunmatched
  • Microsoft Projectunmatched
  • Microsoft SharePointunmatched
  • Microsoft Wordunmatched
  • Multitaskingunmatched
  • Power BIunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Product Lifecycleunmatched
  • Product Managementunmatched
  • Project Controlunmatched
  • Project Management Softwareunmatched
  • Project Planningunmatched
  • Project Trackingunmatched
  • Project/Program Managementunmatched
  • Riskunmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • Standard Operating Procedures (SOP)unmatched
  • T-1 / DS1unmatched
  • Team Lead/Managerunmatched
  • Team Playerunmatched
  • Writing Skillsunmatched

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