Specialized Roles:
QMS Leader
Job in
Harrisonburg, Rockingham County, Virginia, 22802, USA
Listing for:
QCS Staffing
Full Time
position
Listed on 2026-11-11
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Be part of a next-generation pharmaceutical project that’s transforming how medicines are made. We’re supporting a major new-build facility in Virginia, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We’re looking for an QMS Leader to support this project and help deliver this world-class program.
What you’ll deliver- Develop, implement and maintain the project-wide QMS from design and procurement through construction, CQV, operational readiness, startup and final handover.
- Translate existing Global Facilities Delivery (GFD) governance, corporate procedures and work instructions into a project-specific quality manual, playbooks and controlled workflows.
- Use approved AI tools, including Claude, to analyze standards, regulatory guidance and GFD documents and support procedure development with appropriate human review.
- Continuously maintain project quality documentation as regulations, project conditions, delivery requirements and feedback evolve.
- Bachelor’s degree in Civil, Mechanical, Electrical or Structural Engineering, or Construction Management.
- Extensive Quality Management Systems experience in heavy industrial, pharmaceutical, manufacturing, infrastructure, energy or major capital project environments.
- Experience in a Quality Manager, Quality Systems Lead or Quality Program Implementation leadership role.
- Proven development and implementation of enterprise-level or project-specific quality governance systems for multibillion-dollar projects or mega-projects.
- Demonstrated engineering audit leadership, management of NCRs, root‑cause analysis and CAPA programs.
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