SR. OPERATIONAL READINESS PROJECT MANAGER (CONTRACT)

The Senior Project Manager of Operational Readiness will be responsible for leading and managing projects that ensure critical program timelines and manufacutring handover are met with success. This role will involve coordinating cross-functional teams, developing and implementing operational strategies, and ensuring that all systems, processes, and personnel are prepared for new initiatives, products, or changes. The ideal candidate will possess strong project management skills, a deep understanding of operational processes, and an understanding of CQV processes and execution. The candidate will need to have the ability to communicate effectively with stakeholders at all levels.

Roles and Responsibilities :

• Lead and manage complex projects focused on operational readiness, ensuring alignment with organizational goals and objectives.
• Develop project plans, timelines, and resource allocation strategies to achieve project milestones.
• Identify and track any cGMP activities needed to ensure on time delivery of suites and associated equipment and procedures to Manufacturing (will shift / change as new suites / areas are scheduled to come online) including but not limited to :
• Coordination of multiple equipment commissioning and validation activities (EMPQ, APS, manufacturing process equipment) in coordination with program timelines
• Coordination of cGMP operational readiness programs, such as cleanroom cleaning, equipment cleaning, gowning program, training, manufacturing shake-down run
• Ensure cGMP procedures are developed and approved in time to support clinical (and eventually commercial) production activities
• Collaborate with cross-functional teams, including operations, IT, manufacturing, CQV, QA, QC etc., to gather requirements and ensure alignment on project goals.
• Communicate project updates, risks, and issues to stakeholders, ensuring transparency and engagement throughout the project lifecycle.
• Hold daily and weekly meetings with stakeholders to track status, discuss challenges and provide visibility to upcoming activities.
• Provide input to OR management regarding status of the project.
• Conduct comprehensive assessments of current operational processes, identifying areas for improvement and ensuring readiness for new initiatives.
• Analyze operational readiness gaps and develop strategies to address them.
• Develop detailed timeline, with activity owners and key deliverables. This process stems following construction handover. Core responsibility to coordinate CQV efforts, and subsequent handover of equipment following CQV to first cGMP use by area owner.
• Confirm that all necessary activities have been captured on the schedule.
• Identify critical path for delivery of various project milestones.
• Ensure all prerequisites are met, and sequence of steps are mapped out for each of the required activities.
• Develop and implement change management strategies to facilitate smooth transitions for new processes, systems, or products.
• Create training materials and conduct training sessions to ensure personnel are equipped to adapt to changes.
• Identify, assess, and mitigate project risks, ensuring that potential issues are addressed proactively.
• Develop contingency plans to minimize disruption to operations.
• Develop mitigation strategies and communicate how the schedule can be maintained despite challenges.
• Create progress / risk dashboard and communicate to site leadership regularly.
• Establish key performance indicators (KPIs) to measure operational readiness and project success.
• Monitor and report on project performance, adjusting as necessary to meet objectives.
• Maintain comprehensive project documentation, including project plans, risk assessments, and status reports.
• Prepare and present project updates to senior leadership and other stakeholders.
• Promote a culture of continuous improvement within the organization by identifying opportunities to enhance operational efficiency and effectiveness.
• Stay informed of industry trends and best practices related to operational readiness and project management.

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