QA Manager/Senior Manager (Development/Commercial)
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 will function as the QA-designated subject-matter expert for commercial and development products. Manage and perform QA activities related to product compliance and operations, including all aspects of quality assurance for development and commercial product quality, manufacturing and testing oversight, timely product release, and effective resolution of Quality issues.
- Manage all aspects of Quality activities related to the company’s products timely, effectively and with minimum supervision.
- Maintain product knowledge, including product history. Generate annual product quality report.
- Review master and executed batch manufacturing and testing records, and associated records (deviations, change requests, protocols, reports, etc.). Recommend batch disposition.
- Identify and review Quality issues, develop solution proposals and decisions with input from QA management, and effectively communicate and implement these internally/externally.
- Establish and maintain effective working relationships with key internal and external stakeholders. Work with key stakeholders to assure resolution of compliance issues.
- Excellent communication skills (verbal and written). Fosters work environment focused on quality, learning, respect, transparency, open communication, collaboration, integration and teamwork.
- Manage product deviations and/or concerns, including complaints and adverse events investigations, including corrective actions with input from QA Management.
- Collaborate with Regulatory Affairs to assess changes and exceptions for regulatory impact to ensure appropriate notification to regulators. Support, manage and represent during regulatory inspections as tasked, propose responses and corrective actions.
- Perform internal/external audit activities if requested.
- Follow current regulatory guidelines.
- Notify management of significant potential compliance issues that may impact supply chain.
- Represent QA at internal and external meetings to ensure compliance, and CTL/CMO compliance with Dynavax, own and regulatory standards. Manage CTL/CMO to ensure compliance with the terms of agreements.
- Coordinate with Technical Operations, Analytical Technology and other departments to ensure Quality compliance and operations at all times.
- Provide Quality expertise, advice, and/or assistance across the organization, as required.
- Travel up to 20%, if required.
- Other duties as assigned.
- Manager / Senior manager with a BS degree in life sciences, bioengineering or related field, and 5+ years (7+ for Senior Manager) of quality experience in biopharmaceutical or vaccine industry, plus 2 years’ management experience in QA/QC supporting development and commercial products, including licensure.
- Broad to in-depth knowledge of FDA regulatory requirements for biologics, especially vaccines or pharmaceuticals.
- Experience with regulatory inspections and licensure, national and international requirements.
- Effective communicator with proven ability to clearly communicate complex information and concepts.
- Flexible approach to problem-solving, adept negotiator and effective troubleshooter.
- Proven ability to establish and sustain collaborative working internal and external stakeholder relationships, strong team orientation and requiring minimum supervision.
- Strong organizational skills, effective prioritization, multitasking, great attention to detail.
- Highly ethical, flexible and goal-oriented driver. Works well under pressure, meets deadlines effectively.