Director, Commercial Quality Assurance
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 strategic and operational management and oversight of the Quality Assurance Commercial Operations team.
- Embrace Operational Excellence, Lean Six Sigma, and Quality Risk Management strategies to managing complex processes and partner relationships employing simple, scalable solutions
- Provide Quality oversight of contract manufacturing organizations (CMO) manufacturing commercial product, including:
- Master Batch Record and protocol reviews / approvals
- Deviation/CAPA/change control reviews
- Batch record review / test record review
- Batch disposition
- Shipment authorizations
- Partner with Dusseldorf colleagues on the review and release of commercial products for EU market
- Provide Quality oversight of the CPV program for commercial products
- Lead the Annual Product Quality Review process for commercial products
- Manage post-marketing activities for commercial products, including:
- Product Quality Complaints
- Product Quality Investigations related to Adverse Events
- Market actions, including BPDR and product recall
- Author and maintain Quality Agreements with CMOs, CTLs, and collaboration partners / customer.
- With the Executive Director, create and execute the strategic direction of the QA organization
- Provide QA oversight, collaborate and support internal and external groups to ensure deliverables are met, maintain quality standards, and ensure best practices and consistency across commercial products.
- Develop and implement robust systems, procedures, and KPIs using a risk-based approach.
- Support customer audits, regulatory inspections and inspection readiness programs.
- Stay abreast of current regulatory enforcement trends and regulatory changes and ensure corporate policies and practices are aligned.
- Assist in resolving compliance issues and assessing impact of any gaps or risks.
- Maintain a work environment focused on quality and that fosters respect, open communication, collaboration, integration, and teamwork.
- Other duties as assigned.
- BS/BA 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.
- Prefer at least 2 years’ experience at the director level.
- Knowledge of applicable FDA, EU, and ICH regulatory requirements.
- Experience managing 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; and is effective in meeting tight deadlines.