Specialist, Operations (Project Management)

PAI and Filing Readiness Support

• Support Pre-Approval Inspection (PAI) and filing-readiness plans by tracking deliverables, owners, due dates, dependencies, and open actions.
• Update readiness trackers and dashboards so milestones, risks, gaps, and recovery actions are visible and current.
• Coordinate meetings, prepare materials, document decisions, and follow up with owners on assigned actions.
• Help organize inspection evidence, procedures, training records, and filing-related documents for review by subject matter experts.
• Raise schedule, documentation, or compliance concerns promptly to the project manager or workstream lead.

Project Portfolio Management

• Maintain project and portfolio records, including project status, priorities, milestones, risks, resource needs, and dependencies.
• Support project intake and portfolio review activities by gathering information and preparing standard summaries.
• Prepare status reports and dashboards using approved templates and data sources.
• Assist project leads with charters, action logs, risk registers, and project closeout documentation.
• Promote accurate, timely updates across project tools and reporting routines.

Change Review Board Leadership

• Coordinate Change Review Board (CRB) logistics, including agenda preparation, intake tracking, meeting materials, minutes, and action follow-up.
• Gather required information from cross-functional partners to support assessment of proposed changes.
• Document decisions, conditions, owners, and due dates clearly and accurately.
• Track changes and open actions through implementation and closure; escalate overdue or blocked items.
• Support updates to CRB templates, metrics, and standard work.

Incident Writing and Investigation Support

• Author and coordinate incident and deviation records in partnership with Operations, Quality, Engineering, Technical Operations, and other subject matter experts.
• Build clear, fact-based event narratives and support problem definition, impact assessment, root-cause analysis, corrective and preventive actions, and on-time record progression.
• Facilitate investigation working sessions, track information requests and approvals, and maintain visibility to investigation milestones and potential delays.
• Apply strong technical writing practices to ensure records are concise, accurate, traceable, and aligned with applicable procedures and cGMP expectations.

Project Scheduling and Operational Excellence

• Develop and maintain integrated project schedules that include activities, logic, dependencies, milestones, critical paths, constraints, and resource assumptions.
• Partner with workstream leads to update progress, evaluate schedule impacts, identify recovery options, and communicate forecast changes.
• Produce routine schedule and milestone reporting for project teams and governance forums, with emphasis on exceptions and decisions required.
• Support continuous improvement initiatives that strengthen planning, governance, cycle time, right-first-time performance, and execution reliability.
• Participate in site tier processes, gemba walks, readiness reviews, and other operational routines as assigned.

Core Competencies

• Project coordination, organization, facilitation, and action tracking.
• Clear written and verbal communication.
• Basic schedule, risk, and dependency management.
• Attention to detail and commitment to data integrity.
• Ability to collaborate across functions, ask questions, and escalate concerns appropriately.
• Adaptability, learning agility, and a continuous-improvement mindset.