Manufacturing Operations Project Lead

1000 Merck Sharp & Dohme LLC; North Carolina; On-site; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical, dental, vision health plans

401(k) retirement plan

Paid holidays & vacation

Sick days

Job summary

MSD is seeking a Senior Specialist, Operations (Project Management) to lead complex projects at the Durham site. You will partner across Operations, Quality, Engineering, and Regulatory to advance filing readiness, change control, and incident investigations, while driving schedule performance and governance excellence.

The role emphasizes independent leadership, risk anticipation, and the ability to deliver high-visibility initiatives in a regulated manufacturing environment.

Qualifications

• Bachelor’s degree in Engineering, Science, Business, Project Management or related field.
• Minimum five years of relevant experience in manufacturing, operations, quality, engineering or project management (three years with a master’s).
• Experience coordinating cross-functional projects, workstreams or governance processes.

Responsibilities

• Coordinate cross-functional PAI and filing-readiness plans with owners, due dates, evidence and escalation paths.
• Maintain readiness trackers and dashboards providing visibility to milestones, risks and decisions.
• Lead portfolio intake, prioritization, sequencing, and governance aligned with site strategy.
• Lead Change Review Board activities and document decisions, actions, and owners.
• Author incident records and support problem solving with clear narratives and CAPAs.
• Develop integrated project schedules and report progress to governance forums.

Skills

Project leadership

Cross-functional coordination

GxP/regulatory awareness

Technical writing

Education

Bachelor’s degree in Engineering, Science, Business, Project Management

Five years manufacturing or regulatory experience

Tools

MS Project

Job description

MSD is seeking a Senior Specialist, Operations (Project Management) to lead complex projects at the Durham site. You will partner across Operations, Quality, Engineering, and Regulatory to advance filing readiness, change control, and incident investigations, while driving schedule performance and governance excellence.

The role emphasizes independent leadership, risk anticipation, and the ability to deliver high-visibility initiatives in a regulated manufacturing environment.