Onsite QA Director, GMP & Regulatory Leadership

ProQuality Network; Virginia; Hybrid; USD 150,000 - 190,000; Full time

Job summary

ProQuality Network is seeking a QA Director to lead Quality Assurance at our Virginia site in a GMP-regulated environment focused on innovative technologies. The role demands strategic and operational leadership, ensuring robust quality systems and regulatory alignment, while guiding cross-functional teams through complex manufacturing and development activities.

The ideal candidate will have extensive GMP QA leadership experience, strong QMS expertise, and a track record of inspection readiness

Qualifications

• Extensive experience in Quality Assurance within GMP-regulated environments.
• Proven leadership in a Director-level or senior QA management role.
• Strong knowledge of Quality Management Systems, regulatory compliance, and inspection readiness.
• Experience in highly innovative or non-traditional regulated environments preferred.
• Background or exposure to xenotransplantation or advanced biotechnologies is highly desired.

Responsibilities

• Provide strategic leadership and oversight of all Quality Assurance functions at the site.
• Ensure design, implementation, and continuous improvement of robust QMS.
• Maintain full GMP compliance with internal standards and regulatory requirements.
• Lead, mentor, and develop QA teams and foster a culture of quality excellence.
• Support manufacturing, operational, and technical activities with quality oversight and risk-based decisions.
• Partner cross-functionally with Manufacturing, Regulatory, and R&D teams.
• Prepare the site for regulatory inspections and audits as a quality representative.

Skills

GMP experience

QA leadership

Regulatory compliance

QMS

Inspection readiness

Cross-functional collaboration

Biotech/pharma environment

Job description

ProQuality Network is seeking a QA Director to lead Quality Assurance at our Virginia site in a GMP-regulated environment focused on innovative technologies. The role demands strategic and operational leadership, ensuring robust quality systems and regulatory alignment, while guiding cross-functional teams through complex manufacturing and development activities.

The ideal candidate will have extensive GMP QA leadership experience, strong QMS expertise, and a track record of inspection readiness