Senior Operations Project Leader in Manufacturing Excellence

Merck & Co.; Durham (NC); On-site; USD 96,000 - 151,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. in Durham, NC seeks a Senior Specialist, Operations (Project Management) to lead complex, high-visibility initiatives as a governance partner across Operations, Quality, Engineering, and Regulatory.

You will drive inspection readiness, filing deliverables, and portfolio priorities while ensuring schedule performance and strong risk management. The role partners with subject matter experts to oversee CRB processes, change control, incident writing, and actionable reporting.

Qualifications

• Bachelor's degree or higher in a related field.
• Minimum five years of experience coordinating cross-functional projects in regulated environments.
• Experience leading or supporting governance processes and portfolio management.

Responsibilities

• Lead cross-functional Pre-Approval Inspection (PAI) and filing-readiness plans with owners, due dates, evidence, and escalation paths.
• Maintain integrated readiness trackers and dashboards for milestones, risks, gaps, decisions, and mitigations.
• Facilitate readiness reviews, governance updates, and action closure with accountable owners.
• Support preparation and quality review of filing-related documents, inspection evidence, and training records.
• Identify risks early and coordinate mitigation for filing and inspection-readiness objectives.

Skills

Project leadership

Cross-functional

Scheduling

Governance

Technical writing

Risk management

Data analysis

Communication

Education

Bachelor's degree in Engineering, Science, Business, Project Management, or a related field

Tools

Microsoft Project

Job description

Merck & Co. in Durham, NC seeks a Senior Specialist, Operations (Project Management) to lead complex, high-visibility initiatives as a governance partner across Operations, Quality, Engineering, and Regulatory.

You will drive inspection readiness, filing deliverables, and portfolio priorities while ensuring schedule performance and strong risk management. The role partners with subject matter experts to oversee CRB processes, change control, incident writing, and actionable reporting.