Vice President, Quality Assurance

LOCATION

An Ambros corporate office or remote from the Employee’s home office.

$280,000 to $327,000 with an annual bonus target of 30%. Final compensation will be commensurate with the candidate’s experience, education, skills, and overall alignment with the role’s requirements.

Yes

Reporting to the Chief Operating Officer, the Vice President of Quality Assurance will serve as the head of the Quality Unit for Ambros Therapeutics, Inc. (“Ambros” or the “Company”), as defined under 21 CFR 211.22, quality control unit (QCU). This individual will be responsible for leading the Company’s Quality Assurance strategy, building scalable quality systems, and ensuring quality and compliance across all development, manufacturing, and commercialization activities.

This is a critical leadership role at a pivotal moment in the Company’s trajectory. Ambros is advancing toward NDA submission and preparing for pre‑approval inspection (PAI), commercial launch, and eventual public‑company operations. The Vice President of Quality Assurance will own the quality infrastructure buildout required to support these milestones and will build and lead the internal quality organization.

• Lead the development, implementation, and continuous improvement of Ambros’ Quality Management System (QMS) to ensure compliance with FDA and other applicable regulatory requirements.
• Own the selection, implementation, and governance of an electronic Quality Management System (eQMS) platform, ensuring 21 CFR Part 11 compliance and scalability for commercial operations.
• Establish and maintain a comprehensive data integrity program across all GxP‑regulated systems and processes.
• Drive quality culture and GxP training programs across the organization, ensuring all personnel understand and uphold quality expectations consistent with regulatory standards and Company policy.
• Own the quality strategy for Investigational New Drug (IND) and New Drug Application (NDA) submission, including authorship and oversight of the Quality Overall Summary (QOS), batch record review, lot disposition, specification governance, and stability program oversight.
• Lead pre‑approval inspection (PAI) readiness planning and execution, including mock inspections, back‑room coordination, and Contract Development and Manufacturing Organizations (CDMO) / Contract Manufacturing Organizations (CMO) site preparation.
• Serve as the primary Quality Assurance representative during FDA and other regulatory inspections and external audits.
• Review and approve quality‑relevant sections of regulatory filings, technical documentation, and validation strategies.
• Build the quality systems infrastructure required for commercial launch, including product release and lot disposition processes, annual product quality review (APQR), and commercial stability programs.
• Establish complaint handling, adverse event quality review, medical device reporting (if applicable), field alert, and recall/market withdrawal procedures.
• Develop and implement post‑market surveillance quality systems and ensure integration with pharmacovigilance and safety operations.
• Partner with Chemistry, Manufacturing, and Controls (CMC), Clinical Operations, Regulatory Affairs, and external partners to ensure Quality oversight across all Good x Practices (GxP), including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP), and Good Documentation Practice (GDP).
• Ensure quality oversight of CMOs, CDMOs, contract research organizations (CROs), and other GxP vendors through robust qualification, audit, and performance management processes.
• Provide leadership for quality risk management, deviation investigations, Corrective and Preventive Action (CAPA) management, and change control across internal and external operations.
• Build and lead the internal Quality Assurance organization, including hiring, developing, and managing direct reports and establishing a scalable team structure (internal, outsourced, or hybrid).
• Collaborate with cross‑functional leadership to integrate…