Director of Quality Assurance

Overview

The Director of Quality Assurance is responsible for leading a comprehensive range of quality assurance activities in support of Fortvita Biologics’ commercial, clinical, and development programs. This role serves as a strategic and tactical leader in quality initiatives, ensuring compliance with Good Clinical Practice (GCP) standards and overseeing the development, implementation, and continuous improvement of quality systems. This role is onsite at the Palo Alto office.

• Provide quality leadership and oversight for multiple clinical studies across all phases of development (Phase 1 to Phase
  3), ensuring activities conducted by Contract Research Organizations (CROs) and other partners comply with FDA, EMA, ICH, and other applicable global regulatory requirements, guidelines, and laws.
• Collaborate closely with Clinical Development teams to plan, organize, and prepare clinically focused regulatory documents for submission to regulatory authorities. Offer strategic input on development plans, including trial design, protocols, and essential clinical development documentation.
• Develop, implement, and maintain Quality Assurance (QA) programs, policies, and procedures to ensure compliance with applicable GxP standards: cGMP for clinical trial materials, GLP for preclinical studies, and GCP for clinical trials.
• Serve as the primary QA liaison with internal teams, external CROs, vendors, contract facilities, and joint development partners, addressing quality issues related to contracts, validation, change management, and other QA-related matters to support key development milestones.
• Lead QA reviews of manufacturing records, clinical trial documentation, and documents submitted to regulatory agencies to ensure accuracy, compliance, and readiness.
• Oversee and manage the GxP auditing program and all associated inspection activities, including regulatory inspections and internal/external audits.
• Lead the administration of the company’s Standard Operating Procedures (SOP) system and GxP training program to ensure compliance and continuous improvement.
• Ensure the company’s electronic systems and document management platforms are compliant with 21 CFR Part 11, overseeing validation and control of document publishing and management systems in collaboration with IT.
• Offer strategic leadership and quality oversight of contractor Quality Systems, including change control, deviations, out-of-specification (OOS) results, and CAPA programs.
• Evaluate and resolve deviations in a timely manner, ensuring effective implementation of corrective and preventive actions, and escalating issues when appropriate.
• Mentor and guide QA team members at all levels, fostering professional development and providing high-level strategic advice to senior management on complex quality and regulatory matters.

BS/BA in a relevant scientific discipline.

• Minimum ten (10) years of related experience in a QA function within the pharmaceutical/biotech industry with knowledge of Quality Systems and Quality Assurance processes, development, implementation and documentation.
• Minimum of eight (8) years of working in a GCP QA function
• Two (2) years of experience at a manager level including supervisory experience of QA personnel.
• SME in GCP guidelines, comprehensive knowledge and familiarity with relevant GxP regulations, ICH, and FDA guidelines critical to clinical development.
• Experience in the clinical trials/drug development process and the Federal law and regulations affecting the pharmaceutical industry.

MS/MA or PhD degree in related discipline; an equivalent combination of education and experience may satisfy the preferred qualifications.

• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable

• Five (5) years of related experience in Quality Systems and Quality Assurance processes, development, and documentation.
• Experience in the biotech or pharmaceutical industry in clinical trials/drug development process and the Federal law…