Senior GMDP QA Manager — Site Quality Lead

Wepclinical; Morrisville (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

FSA/HSA

Disability insurance

Retirement plan with company match

Paid time off

Job summary

WEP Clinical in the United States is seeking a Senior GMDP Quality Assurance Manager to lead the site QA function, ensuring GDP/GMP compliance for distribution and manufacturing activities.

You will own quality records, drive risk-based improvements, supervise QA staff, and partner with supply chain, regulatory affairs, and operations to support client solutions across post-approval and clinical trial supply.

Qualifications

• Bachelor's degree in a life sciences field or engineering preferred.
• 7+ years of QA experience in GMP/GDP environments.
• Ability to lead cross-functional teams and make risk-based decisions.
• Experience with UK, FDA, and EU regulations in manufacturing and distribution.
• Strong communication and stakeholder management skills.

Responsibilities

• Lead the site QA function for GDP/GMP operations and ensure product quality and patient safety.
• Oversee QMS, deviations, CAPAs, change controls, and training to maintain compliance.
• Ensure regulatory readiness, audit responses, and inspection readiness.
• Partner with supply chain, regulatory, and operations to drive risk-based improvements.
• Manage and develop the QA staff and foster a quality-first culture.

Skills

Leadership

GxP compliance

Regulatory knowledge

QA management

Data integrity

Education

Bachelor's degree in Life Sciences or related field

Job description

WEP Clinical in the United States is seeking a Senior GMDP Quality Assurance Manager to lead the site QA function, ensuring GDP/GMP compliance for distribution and manufacturing activities.

You will own quality records, drive risk-based improvements, supervise QA staff, and partner with supply chain, regulatory affairs, and operations to support client solutions across post-approval and clinical trial supply.