In this role, the Senior Project Manager will provide centralized project management, coordination, and visibility for deviations across the Combination Product Organization. The position is intended to work together with deviation owners, functional leaders, quality, engineering, manufacturing sites and other stakeholders to organize deviation activities and manage timelines.
The Senior Project Manager will provide the workspace and follow-through needed to help teams progress deviations efficiently and in accordance with applicable quality system requirements. The role is not expected to serve as the technical investigator or deviation owner.
The successful candidate will be an organized and collaborative project leader who can manage multiple high-priority workstreams, facilitate cross-functional discussions, identify and track timeline risks, and provide clear status reporting to CPO leadership. Experience supporting deviations and root cause investigations is preferred but not required.
Responsibilities
Provide centralized project management support for the CPO organization from initiation through investigation, action completion, and record closure.
Responsible for assembling highly complex project plans and teamwork assignments, directing and monitoring work efforts daily, identifying resource needs, performing quality review; and escalating functional, quality, timeline issues appropriately.
Responsible for tracking key project milestones and adjusting project plans and/or resources to meet the needs of customers. Coordinates communication with all areas of the enterprise that impacts the scope, budget, risk and resources of the work effort being managed. This includes:
Establishing and maintaining deviation trackers, project plans, timelines, dashboards, action logs, and reporting tools.
Coordinating activities across CPO functions and ensure that deliverables, dependencies, owners, and due dates are clearly defined.
Facilitating reoccurring deviation review meetings, focused working sessions, and leadership updates.
Monitor deviation progress, aging, upcoming due dates, overdue actions, extension needs, and path to closure and escalate unresolved issues through the appropriate governance channels.
Support prioritization based on business need, compliance risk, potential product impact, and organizational commitments.
Help teams organize investigation activities, including problem statements, impact assessments, root cause analyses, corrective and preventive actions, and effectiveness verifications, as applicable.
Develop concise portfolio metrics and summaries that give CPO leadership visibility into status, trends, risks, and resource needs.
Maintain organized records of meetings, decisions, action items, commitments, and supporting documentation.