Senior GMDP QA Manager – Site Quality & Compliance

WEP Clinical; Morrisville (NC); On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401K match

Job summary

WEP Clinical is seeking a Senior GMDP Quality Assurance Manager to lead the site QA functions for US distribution and manufacturing activities, ensuring regulatory compliance and continuous improvement across GDP/GMP operations. You will partner with supply chain, project management, and other departments to deliver compliant client solutions.

The ideal candidate will bring 7+ years in pharma QA, strong leadership, and deep knowledge of GDP/GMP, data integrity, change control, and CAPA

Qualifications

• Bachelor’s degree or higher in a pharmaceutical, life sciences, or engineering field.
• Experience with GMP/GDP regulations and quality systems.
• Proven leadership and cross-functional collaboration abilities.
• Strong decision-making under time-sensitive conditions.

Responsibilities

• Oversee day-to-day site quality operations and ensure timely completion of critical quality records.
• Lead the Quality Management System and maintain GDP/GMP compliance.
• Own site quality performance metrics and drive data-led CAPAs and improvements.
• Provide hands-on QA oversight of warehouse, distribution, manufacturing, and packaging activities.
• Conduct risk assessments and act as escalation point for GxP issues.
• Oversee deviations, investigations, change controls, and product disposition.
• Coordinate with EU/UK Qualified Persons on communications and batch certification.

Skills

Attention to detail

Proactive and self-motivated

Calm under pressure

Leadership

Education

Bachelors or higher in pharmaceutical, life sciences, or engineering

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Job description

WEP Clinical is seeking a Senior GMDP Quality Assurance Manager to lead the site QA functions for US distribution and manufacturing activities, ensuring regulatory compliance and continuous improvement across GDP/GMP operations. You will partner with supply chain, project management, and other departments to deliver compliant client solutions.

The ideal candidate will bring 7+ years in pharma QA, strong leadership, and deep knowledge of GDP/GMP, data integrity, change control, and CAPA