Director, Development Quality Assurance
US-Emeryville, CA OR Remote
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
This position is responsible for quality assurance as it applies to research and development, and early-phase clinical programs.
- Provides oversight and strategic input to CMC aspects of products in development (e.g., process and test method qualifcation for release, in-process, and stability, etc.).
- Provides QA oversight for manufacturing, testing, and release of clinical trial material for products in development
- Provides QA oversight of nonclinical development (e.g., toxicology studies)
- Ensures proper knowledge transfer between research, development, and CMC teams during phases of product development
- Supports R&D and business development in technology evaluations or due diligence activities
- Ensures evaluation of impact of new or updated regulations (local and global) and the implementation of the regulations into the R&D quality management system
- Establishes, maintains and provides direction for phase appropriate Quality standards governing the life-cycle for development of products across all projects/ programs
- Collaborates with Regulatory Affairs on regulatory filings related to development products
- Ensures that QA Development business deliverables and timelines are met.
- Develops and implements systems, procedures, and KPIs using a risk-based approach.
- Supports inspections and inspection readiness programs.
- Assists in resolving compliance issues and assessing impact of any gaps or risks.
- Maintains a work environment focused on quality and that fosters respect, open communication, collaboration, integration, and teamwork.
- Performs other duties as assigned.
- MS/PhD degree in a scientific or health-rated field, with 10+ years of progressive experience in the pharmaceutical and/or biotechnology industry, and at least 5+ years cGxP experience managing a team and/or GxP projects.
- Experience in Quality Assurance preferred but not required.
- 2 years’ experience at the director level preferred, but not required.
- Knowledge of applicable FDA, EU, and ICH regulatory requirements.
- Experience managing or supporting health authority inspections.
- Must be an effective communicator with proven abilities to communicate complex information and concepts with clarity, plus flexibility in approach to problem-solving, negotiating, and troubleshooting issues and problems.
- Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team orientation, and the ability to work independently.
- Ability to effectively prioritize and manage multiple projects and tasks.
- Highly ethical, flexible, action- and goal-oriented; work well under pressure; effective in meeting tight timelines.
- Ability to stand or sit for prolonged periods.
- Must be able to perform repeating motions that may include the wrists, hands and/or fingers.
- Occasional travel required, as needed.
- Full COVID-19 vaccination is required for this position.
Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.