Angitia Biopharmaceuticals

QA Engineer

• Provide strategic leadership and hands-on oversight for the GxP Quality Management System, ensuring compliance with FDA, EMA, and ICH guidelines relevant to clinical‑stage activities.
• Own the eQMS and its core modules, including governance, optimization, user support, and coordination with IT, internal stakeholders, and vendors.
• Lead document management processes, ensuring controlled documents (SOPs, policies, forms, work instructions) are current, accurate, and aligned with clinical and CMO/CRO operations.
• Oversee the GxP training program, including role‐based curricula, onboarding, training effectiveness, and system performance within the eQMS.
• Direct the deviation and nonconformance process, ensuring high quality investigations, root cause analysis, and effective corrective and preventive actions.
• Own the CAPA system, ensuring quality issues are captured, assessed, prioritized, and addressed with clear plans and effectiveness checks.
• Manage change control processes for GxP documents, quality systems, and relevant operational changes.
• Establish, monitor, and communicate Quality System KPIs to senior leadership; identify trends and drive proactive improvements.
• Support internal and external audits, regulatory inspections, and inspection readiness activities.
• Collaborate with CMO, CDMO, and CRO partners to ensure alignment and oversight of Quality System expectations, documentation, and compliance.
• Contribute to Quality strategy and governance as the company advances into later‑stage clinical studies and early commercial readiness.

Director, Quality Assurance – Quality Systems

Attorney

• Develop and execute a global IP strategy aligned with corporate and program objectives.
• Lead the building, prosecution, and lifecycle management of a worldwide patent portfolio, including composition of matter, formulation, method of use, and platform innovations.
• Oversee patent term extension (PTE), supplementary protection certificates (SPCs), and regulatory exclusivity strategies.
• Provide freedom-to-operate (FTO), validity, enforceability, and infringement analyses to inform R&D, clinical, manufacturing, and commercial decisions.
• Partner with scientific teams to identify, capture, and protect inventions early and effectively.
• Lead global trademark strategy and trade secret protection.
• Provide strategic IP guidance for licensing, collaborations, co-development agreements, financings, and M&A transactions.
• Lead IP due diligence efforts for inbound and outbound transactions.
• Draft, negotiate, and advise on IP-related provisions in research, clinical, manufacturing, supply, and commercial agreements.
• Structure IP frameworks that preserve long-term asset value while enabling strategic partnerships.
• Oversee IP-related disputes and pre-litigation risk assessments.
• Manage outside counsel in patent litigation, U.S. inter partes review (IPR), post-grant proceedings, European oppositions, and other adversarial actions.
• Develop proactive risk mitigation strategies in key global jurisdictions.
• Manage and optimize relationships with external patent and litigation counsel, ensuring quality and cost discipline.
• Establish scalable IP processes and governance appropriate for a company transitioning toward commercialization.
• Foster a high-performing, collaborative, and business-oriented legal team culture.
• Provide leadership oversight and development support to the broader in-house legal team over time.

Director, Quality Assurance – Quality Systems

Executive Director, Intellectual Property – Legal