The client is a bio-pharmaceutical company near Emeryville focused on commercialising innovative vaccines to prevent disease. With over 20 years of experience in this field our client is currently partnering up with well-known company to upgrade vaccinations to be more effective and protect people faster. The company is a global operation company with over 220 employees. 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.Responsibilities
- All quality areas are actively managed by you.
- You will be in charge of annual product reports and built knowledge about the product and product history
- Also within your control: Batch record review (master&executed) as well as deviations, change requests, protocols, reports, etc. and recommend batch disposition.
- Collaborate with QA Management to handle quality issues and develop solutions for and execute on them.
- Build and maintain relationships with internal and external stakeholders.
- Collaborate with Regulatory Affairs to assess changes and exceptions for regulatory impact to ensure appropriate notification to regulators.
- Perform internal/external audit activities if requested.
- You are the person of contact for advice and support in quality purposes. Attend external meetings to ensure compliance, and CTL/CMO compliance. Manage CTL/CMO to ensure compliance with the terms of agreements.
- There might be travel required up to 20%
- Up to 7 years of experience in Quality Assurance including 2 years of experience in managing a team.
- BS degree in life sciences, or related field.
- Experience with products in development and commercial stages
- Strong organisational skills, effective prioritisation, multitasking, great attention to detail.
- Highly ethical, flexible and goal-oriented driver. Works well under pressure, meets deadlines effectively.