Senior QA Director, GMP Compliance & Inspections

Wilmington PharmaTech Company; Newark (DE); On-site; USD 140,000 - 220,000; Full time

Job summary

Wilmington PharmaTech is seeking a Quality Assurance Director to oversee all QA functions supporting API development and commercial manufacturing. The role ensures cGMP compliance, global regulatory standards, and a culture of quality.

The Director provides strategic leadership, maintains inspection readiness, and partners with Manufacturing, Regulatory, and R&D to drive continuous improvement and operational excellence across the organization. Reports to senior leadership.

Qualifications

• Bachelor’s degree or higher in Chemistry or Life Sciences.
• 5+ years QA experience in pharmaceutical manufacturing or CDMO.
• Direct leadership at management or director level.
• Extensive hands-on experience with cGMP regulations and FDA inspections.

Responsibilities

• Lead and oversee the Quality Management System (QMS) ensuring regulatory compliance across development and commercial programs.
• Maintain inspection readiness and lead regulatory inspections, customer audits, and third-party quality assessments.
• Provide quality oversight for batch records, disposition, deviations, investigations, CAPA, and change controls.
• Apply risk management principles to support development, scale-up, and manufacturing activities.
• Collaborate with Manufacturing, Technical Operations, Supply Chain, and R&D to integrate quality into operations.

Skills

Quality Assurance

Leadership

Cross-functional collaboration

Regulatory compliance

cGMP

Education

Bachelor's degree or higher in Chemistry or Life Sciences

Job description

Wilmington PharmaTech is seeking a Quality Assurance Director to oversee all QA functions supporting API development and commercial manufacturing. The role ensures cGMP compliance, global regulatory standards, and a culture of quality.

The Director provides strategic leadership, maintains inspection readiness, and partners with Manufacturing, Regulatory, and R&D to drive continuous improvement and operational excellence across the organization. Reports to senior leadership.