Fortvita Biologics · 2 days ago
Director of Quality Assurance
Palo Alto, CA
Full-time
Onsite
Director/Executive
10+ years expFortvita Biologics is a company focused on quality assurance in the pharmaceutical and biotech industry. The Director of Quality Assurance will lead quality assurance activities, ensuring compliance with regulatory standards and overseeing quality systems for clinical and commercial programs.
Biotechnology
Responsibilities
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 compliance to clinical trial materials
GLP for compliance to preclinical studies
GCP for compliance to 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
Qualification
Required
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
Access data in computer data bases
Answer emails/telephones
Compile data/statistics
Coordinate requests, meetings, and events
Coordinate travel arrangements
Establish, organize, and maintain hardcopy and electronic filing systems
Input data into computer programs
Prepare reports
Proofread documents
Schedule appointments
Use computer programs and software packages
MS Office, required
Veeva Quality Docs, Training and or QMS, required
Electronic/cloud-based documentation and filing systems
Personal computer
Computer peripheral equipment
Subject to interruptions
Subject to varying and unpredictable situations
Manages multiple tasks simultaneously
Handle pressure due to multiple calls and inquiries
Handle pressure due to deadline requirements
Requires judgment that could affect image of Fortvita Biologics
Tobacco-free work environment
Able to travel by car/air (domestic/international) – Est > 20%
Light physical effort
Mostly sedentary work
Occasional standing/walking
English languages (verbal, written and speaking ability)
Excellent verbal communication and telephone skills
Excellent written communication skills
Preferred
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 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 and regulations affecting the pharmaceutical industry
Five (5) years of experience as a QA Manager including supervisory experience of QA personnel
Extensive knowledge and familiarity with relevant GxP regulations, ICH, and FDA guidelines critical to clinical development
Company
Fortvita Biologics
Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase