Specialist, Operations (Project Management)
About The Position
The Specialist, Operations (Project Management) supports the Durham manufacturing site by coordinating project activities, maintaining accurate project information, supporting change controls and incident writing, and helping teams complete actions for Pre-Approval Inspection (PAI) and filing readiness. The role collaborates across Operations, Quality, Engineering, Technical Operations, Automation, Regulatory, and other functions, with direction and coaching from project leaders and subject matter experts. The position supports PAI and filing-readiness planning, portfolio records and reporting, Change Review Board (CRB) coordination, incident and deviation documentation and investigation activities, integrated project scheduling, and continuous improvement. It includes coordinating meetings and follow-up, tracking deliverables and actions, maintaining dashboards and schedules, documenting decisions, and raising compliance, schedule, or documentation concerns. Periodic off-shift or weekend support may be required based on business needs, inspection-readiness activities, incident response, or project milestones. Travel is up to 10%.
Requirements
- Bachelor's degree in Engineering, Science, Business, Project Management, or a related field.
- At least two years of relevant experience in manufacturing, operations, quality, engineering, project management, or a related regulated environment.
- Demonstrated written and verbal communication skills, including the ability to create clear technical or business documentation.
- Ability to work independently, manage competing priorities, and escalate issues with clear recommendations.
- Project coordination, organization, facilitation, and action-tracking skills.
- Basic schedule, risk, and dependency management skills.
- 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.
Nice To Haves
- Experience in pharmaceutical, biologics, vaccine, medical device, or other regulated manufacturing environments.
- Familiarity with inspection readiness, regulatory filings, change control, deviations, investigations, or CAPAs.
- Experience with Microsoft Project or similar planning and tracking tools.
- Basic knowledge of cGMP, root-cause analysis, FMEA, Lean, or Six Sigma methodologies.
- Lean Six Sigma certification or comparable project management or continuous-improvement training.
Responsibilities
- Track PAI and filing-readiness deliverables, owners, due dates, dependencies, open actions, milestones, risks, gaps, and recovery actions.
- Coordinate readiness meetings, prepare materials, document decisions, and follow up with action owners.
- Organize inspection evidence, procedures, training records, and filing-related documents for subject matter expert review.
- Promptly raise schedule, documentation, or compliance concerns to the project manager or workstream lead.
- Maintain project and portfolio records, including status, priorities, milestones, risks, resource needs, and dependencies.
- Support project intake and portfolio reviews 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.
- Coordinate Change Review Board logistics, including agenda preparation, intake tracking, meeting materials, minutes, and action follow-up.
- Gather cross-functional information to support assessment of proposed changes and accurately document decisions, conditions, owners, and due dates.
- Track changes and open actions through implementation and closure, escalating overdue or blocked items.
- Support updates to CRB templates, metrics, and standard work.
- Author and coordinate incident and deviation records with Operations, Quality, Engineering, Technical Operations, and other subject matter experts.
- Develop fact-based event narratives and support problem definition, impact assessment, root-cause analysis, corrective and preventive actions, and timely record progression.
- Facilitate investigation working sessions, track information requests and approvals, and monitor investigation milestones and potential delays.
- Ensure incident and deviation records are concise, accurate, traceable, and aligned with applicable procedures and cGMP expectations.
- Develop and maintain integrated project schedules covering activities, logic, dependencies, milestones, critical paths, constraints, and resource assumptions.
- Work 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, emphasizing exceptions and required decisions.
- 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.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and their families.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
