Vice President Quality Assurance

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

Position Title: Vice President, Quality Assurance

Position Summary:

Reporting to the CEO, the Vice President, Quality Assurance, will lead the continued development and improvement of Mighty’s Quality Management System (QMS). This role will oversee GxP quality activities across clinical and commercial programs and provide guidance and mentorship to a growing team of QA professionals.

Responsibilities:

• Provide leadership, direction, and enhancement of the Mighty Quality Management System (QMS).
• Maintain Quality oversight and management of GXP activities including external clinical and commercial stage CMOs, contract testing laboratories and clinical trial CROs.
• Oversee Quality activities associated with clinical trial initiation and maintenance as well as commercial launch and compliance activities.
• Create and maintain a status of Regulatory Inspection readiness for both clinical and commercial stage systems.
• Maintain a company-wide Quality culture through participation in team meetings as well as individual mentorship.
• Ensure that continuous GXP training is implemented and adapted according to regulatory compliance requirements, as well as functional department and overall company needs.
• Provide overall leadership for the Quality Assurance function.
• Develop and mentor a team of Quality professionals.
• Excellent verbal and written communication skills. Ability to effectively communicate Quality direction cross-functionally, based on regulations and business needs.
• Demonstrated ability to apply knowledge strategically and operationally across projects within a matrix environment with strong negotiation and facilitation skills.
• Strong organization skills with the ability to effectively multi-task and prioritize.
• Ability to flexibly adapt to changing business needs and meet timelines within a fast-paced environment.
• Self-motivated with sound judgement and problem-solving skills.
• Strong people manager with ability to achieve results through principle-based leadership.

Requirements:

• Bachelor's degree in a scientific or engineering discipline.
• Minimum of 15 years pharmaceutical industry experience in Quality Assurance including experience in small molecule manufacturing in both clinical and commercial stage projects.
• Demonstrated experience building and leading QA teams.
• Experience supporting NDA approval, regulatory inspections, commercial launch, and post-approval quality activities preferred.
• Strong understanding of 21CFR, ICH, FDA and EU/UK regulatory standards /guidance documents.
• Proven track record of leadership and building relationships with internal and external Quality customers.