VP, Quality Assurance & GxP Compliance Leader

Mighty Therapeutics; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Mighty Therapeutics seeks a Vice President, Quality Assurance to lead the ongoing development of the Quality Management System and oversee GxP activities across clinical and commercial programs. You will mentor a growing QA team and ensure compliance for NDA approvals, inspections, and launches.

Reporting to the CEO, you will guide quality strategy, partner across functions, and drive continuous improvement in a fast-paced environment within the biotech space.

Qualifications

• Bachelor's degree in a scientific or engineering discipline.
• 15+ years pharmaceutical industry experience in Quality Assurance including small molecule manufacturing (clinical and commercial).
• Experience building and leading QA teams.
• Experience supporting NDA approvals, regulatory inspections, launches and post‑approval activities.
• Strong understanding of 21 CFR, ICH, FDA and EU/UK guidance/documents.
• Proven leadership and relationship-building with QA customers.

Responsibilities

• Lead development and improvement of the QMS across clinical and commercial programs.
• Oversee GXP activities with CMOs, CROs, and testing laboratories.
• Manage QA activities for clinical trials initiation and maintenance and commercial launches.
• Maintain inspection readiness for clinical and commercial systems.
• Foster a quality culture and mentor QA staff across the organization.
• Provide ongoing GXP training aligned with regulatory requirements.
• Lead the QA function and guide cross-functional quality direction.

Skills

Leadership

QA Leadership

Regulatory compliance

Cross-functional communication

Mentorship

Negotiation

Project management

GxP knowledge

Education

Bachelor's in science/engineering

Job description

Mighty Therapeutics seeks a Vice President, Quality Assurance to lead the ongoing development of the Quality Management System and oversee GxP activities across clinical and commercial programs. You will mentor a growing QA team and ensure compliance for NDA approvals, inspections, and launches.

Reporting to the CEO, you will guide quality strategy, partner across functions, and drive continuous improvement in a fast-paced environment within the biotech space.