Vice President, Quality Assurance

Ambros Therapeutics, Inc.•Irvine, CA

2d•$280,000 - $327,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree or higher in life sciences, chemistry, pharmaceutical sciences, or related field required.
Minimum of 15 years of progressive experience in Quality Assurance within the biotechnology or pharmaceutical industry, with at least 3 years in a senior leadership role (Head of, Vice President, or equivalent).
Direct experience supporting at least one NDA or BLA filing and associated pre-approval inspection (PAI).
Demonstrated track record of building and scaling quality organizations and systems in emerging or growth-stage biotechnology companies.
Strong expertise in GxP quality systems, including GMP and GCP, with working knowledge of GLP, GVP, and GDP.
Experience with CMO/CDMO quality oversight across both domestic and international manufacturing sites.
Proven track record of building and scaling quality organizations and systems in emerging or growth-stage biotechnology companies.
Demonstrated integrity, accountability, and commitment to quality, regulatory compliance, and patient safety.
Problem solver with an entrepreneurial spirit, curious and innovative mindset, and ability to thrive in an agile environment typical of a growing biotechnology company.
Ability to assess the inherent risks of a situation, their potential impact on a project and, based on this information, involve the appropriate team members to make timely decisions.
Proven ability to develop and sustain relationships with regulatory agencies, external partners, CROs, CDMOs, CMOs, and other vendors.
Able to participate in a robust technical dialogue with regulators, auditors, quality professionals, and cross-functional teams.
Excellent leadership skills and demonstrated ability to manage cross-functional project teams of highly performing and motivated individuals.
Skilled in Quality Assurance leadership and an understanding of drug development processes including CMC development, clinical trial operations, manufacturing, and regulatory compliance.
Demonstrated ability to organize, prioritize, and work effectively with minimal supervision in a constantly changing environment.
Must have knowledge of and be willing to comply with all regulatory/compliance policies and best practices consistent with the role and Company’s policies.
Superior verbal, written, and presentation communication skills in English, with the ability to engage effectively across all levels of the Company and with external stakeholders.
Ability to read and comprehend complex materials, including medical and scientific literature, policies, procedures, and instructions in English; write reports and memos; use logic and data to solve problems; assess needs and take appropriate actions; all with reasonable independence, business judgment, and professional discretion.
Upholds high ethical standards and maintains integrity in all activities.
Proficient with Microsoft Office Suite and related software

Nice To Haves

Advanced scientific degree (PhD, MS, or equivalent) in life sciences, chemistry, pharmaceutical sciences, or related strongly preferred.

Responsibilities

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 quality into all operational activities and ensure compliance throughout the product lifecycle.
Present quality metrics, risk posture, and inspection readiness status to the executive leadership team and Board of Directors as required.