Senior Specialist, Operations (Project Management)

MSD • Durham, NC

1d • $96,200 - $151,400 • Onsite

About The Position

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 governance, reporting, and decision-making practices that support site and business objectives. The 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.

The role coordinates PAI and filing-readiness plans and maintains readiness trackers and dashboards. It manages the functional project portfolio, leads the Change Review Board process, authors and coordinates incident and deviation records, and develops integrated project schedules. The position also supports continuous improvement and participates in site operational routines. 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% based on business needs.

Requirements

• Bachelor’s degree in Engineering, Science, Business, Project Management, or a related field.
• At least 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.
• Ability to work effectively across functions and influence without direct authority.
• High attention to detail, strategic thinking, adaptability, and commitment to data integrity.

Nice To Haves

• 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 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.

Responsibilities

• 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 showing milestones, risks, gaps, decisions, and recovery actions.
• Facilitate readiness reviews, working sessions, and governance updates; document decisions and drive action closure.
• Partner with subject matter experts to prepare and quality-review filing-related documents, inspection evidence, procedures, training records, and supporting materials.
• Identify schedule or compliance risks early and coordinate mitigation plans.
• Manage the functional project portfolio, maintaining a current inventory of projects, priorities, resource needs, interdependencies, benefits, risks, and status.
• Lead portfolio intake, prioritization, sequencing, and review processes using criteria aligned with site strategy, capacity, compliance, and business value.
• Develop portfolio summaries and dashboards to support 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.
• Lead the Change Review Board 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 captured and communicated.
• Monitor the change portfolio through implementation and closure, escalating aging actions, unresolved dependencies, and risks.
• Improve Change Review Board standards, templates, metrics, and workflows.
• Author and coordinate incident and deviation records with Operations, Quality, Engineering, Technical Operations, and other subject matter experts.
• Build 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 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.
• 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, emphasizing 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.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior