Program Manager

Sr. Project Manager

• Framingham, MA
  
  

Job Description

The client is in the process of remediating pre-identified Data Integrity gaps in some of their manufacturing and QC equipment as a result of an FDA observation. They will also be proactively assessing the rest of their equipment. We currently have 3 validation engineers supporting this remediation work.

The PM will be the technical assessor of all the content being created by the project team. This individual is expected to serve as a cross-functional lead for the validation team for all remediation initiatives, having a strong background in past remediation work, familiarity with user traceability matrices as a method for gap generation, knowledge of protocol development and execution, and the gap closure process.

Project management background, remediation experience, equipment and/or systems validation, user traceability matrices, CFR Part 11 Compliance, can establish a workflow from start to finish without preceding guidance,

• Support and provide technical expertise in cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations.
• Review the current deviation initiation and workflow to find and implement areas of improvement. Work with team and director to find and implement process improvement.
• Communicate progress with site heads.
• Consultant will be responsible for working with Project Lead and Sponsor to set up team by delegating roles and responsible for validation between manufacturing, facilities, IT & Quality, set up project scope, manage milestones and timelines, host meetings with team and stakeholders
• Coordinate scheduling and facilitating meetings, sending out agendas, writing and distributing minutes, managing team documentation, and tracking goals and action items
• They will work directly with stakeholders to ensure deliverables remain on track, measure performance using appropriate project management tools, and report and escalate to management as needed
• Establish, manage, and lead cross-functional project teams
• Manage weekly planning meetings for the Quality team including the updating of operational trackers
• Create and maintain detailed project plans to ensure clarity of deliverables and timing Proactively manage project risks and mitigation plans; follow a communication plan to escalate when necessary
• Participate in the development of project management best practices for the team, including creation of templates and business process improvements