Senior Specialist, Operations (Project Management)

Job Description

Our Manufacturing Operations teams make and supply products with a “Safety First, Quality Always, Inclusion for All” mindset and a focus on continuous improvement. Team members work within the local plant and across the global manufacturing network to support reliable, compliant delivery of high-quality materials and finished products.

The Senior Specialist, Operations (Project Management) supports the Durham manufacturing site as a project leader and governance partner. The role independently leads complex, high-visibility initiatives; advises functional leaders; anticipates execution risks; and establishes the governance, reporting, and decision-making practices needed to achieve site and business objectives. This position works across Operations, Quality, Engineering, Technical Operations, Automation, Regulatory, and other functional areas to advance inspection readiness, filing deliverables, portfolio priorities, change control, incident writing, and schedule performance.

Key Responsibilities

PAI and Filing Readiness

• •Coordinate cross-functional Pre-Approval Inspection (PAI) and filing-readiness plans, including deliverables, owners, dependencies, due dates, evidence, and escalation paths.
• •Maintain integrated readiness trackers and dashboards that provide accurate visibility to critical milestones, risks, gaps, decisions, and recovery actions.
• •Facilitate readiness reviews, working sessions, and governance updates; document decisions and drive action closure with accountable owners.
• •Partner with subject matter experts to support preparation and quality review of filing-related documents, inspection evidence, procedures, training records, and supporting materials.
• •Identify schedule or compliance risks early and coordinate mitigation plans that protect filing and inspection-readiness objectives.

Project Portfolio Management

• •Manage the functional project portfolio by maintaining a current inventory of projects, priorities, resource needs, interdependencies, benefits, risks, and status.
• •Lead portfolio intake, prioritization, sequencing, and review processes using consistent criteria aligned with site strategy, capacity, compliance, and business value.
• •Develop portfolio summaries and dashboards that enable timely decisions, resource alignment, and escalation of constraints.
• •Coach project leads on project charters, scope, milestones, governance, risk management, action tracking, and closeout expectations.
• •Promote disciplined project controls, data accuracy, and a single source of truth across portfolio tools and reporting routines.

Change Review Board Leadership

• •Lead the Change Review Board (CRB) operating rhythm, including agenda development, intake review, meeting facilitation, decision documentation, and follow-up.
• •Coordinate cross-functional assessment of proposed changes for scope, quality, regulatory, technical, operational, validation, supply, schedule, and resource impacts.
• •Ensure change proposals are sufficiently defined for review and that decisions, conditions, owners, and required actions are clearly captured and communicated.
• •Monitor the change portfolio through implementation and closure, escalating aging actions, unresolved dependencies, and risks to the appropriate governance forum.
• •Continuously improve CRB standards, templates, metrics, and workflows to strengthen decision quality, speed, and accountability.

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 leadership and cross-functional facilitation.
• •Portfolio governance, prioritization, risk identification, and executive communication.
• •Integrated scheduling, dependency management, and critical-path thinking.
• •Coaching and capability development.
• •Technical writing, investigation support, and document quality.
• •Ability to influence without direct authority and work effectively in a matrixed environment.
• •High attention to detail, strategic thinking, adaptability, and commitment to data integrity.

Required Education, Experience, and Skills

• •Bachelor’s degree in Engineering, Science, Business, Project Management, or a related field.
• •Minimum of five years of relevant experience in manufacturing, operations, quality, engineering, project management, or a related regulated environment (or three years with a master’s degree).
• •Demonstrated experience coordinating cross-functional projects, workstreams, or governance processes.
• •Demonstrated written and verbal communication skills, including the ability to create clear technical or business documentation.
• •Experience maintaining project plans, schedules, action logs, risk registers, dashboards, or portfolio reports.
• •Ability to work independently, manage competing priorities, and escalate issues with clear recommendations.

Preferred Experience and Skills

• •Experience supporting PAI, general inspection readiness, regulatory filings, licensure, commercialization, or manufacturing start-up activities.
• •Experience leading or supporting a change control or Change Review Board process.
• •Experience authoring or supporting deviations, incidents, investigations, root-cause analyses, and CAPAs.
• •Experience with scheduling and portfolio tools such as Microsoft Project or equivalent systems.
• •Knowledge of cGMP requirements and experience working in vaccine, biologics, pharmaceutical, or other regulated manufacturing environments.
• •Familiarity with formal problem-solving and continuous-improvement methodologies such as RCA, FMEA, Lean, or Six Sigma.
• •Project Management Professional (PMP), Lean Six Sigma, or comparable training and certification.

Work Expectations

• •Periodic off-shift or weekend support may be required based on business needs, inspection-readiness activities, incident response, or project milestones.
• •Travel: Up to 10% based on business needs. #EBRG's #VetJobs #SWE2026

Required Skills:

Adaptability, Adaptability, Analytical Problem Solving, cGMP Compliance, Change Controls, Coaching, Communication Sciences, Data Analysis, Data Integrity, Decision Making, Good Manufacturing Practices (GMP), Inspection Readiness, Inventory Management, Lean Six Sigma Continuous Improvement, Manufacturing, Manufacturing Technologies, Meeting Facilitation, Microsoft Project, Personal Initiative, Pre Approvals, Process Improvements, Process Optimization, Production Planning, Production Scheduling, Project Charters {+ 9 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our