Director, Quality Assurance
Visp
Quality /
Full-time /
Hybrid
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Essential Functions:
- Collaborates across local and global Quality Assurance teams to help provide support, assess risk and evaluate resolution to quality issues.
- Represents Quality Assurance is support of Investigations, Deviations, Change Controls, and CAPAs.
- Ensures timely and effective communication and escalation of quality issues.
- Provides oversight and guidance to external manufacturing partners with respect to GMP manufacturing, investigations and deviations and lot release activities.
- Executes the quality program and to ensure high quality products enter the supply chain.
- Leads or participates in Quality Management Review to monitor process performance, product quality and effectiveness of the quality management system.
- May review and approve quality documentation such as batch records, validation protocols, and reports for compliance.
- Provide oversight for process validation batches and evaluate commercial readiness.
- Collaborate with cross functional teams to ensure manufacture of GMP compliant products.
- Champions and fosters a positive quality compliance culture.
Requirements:
- BS or BA with 12 years relevant industry experience.
- Demonstrate in-depth knowledge of GMPs, FDA/EU regulations and ICH guidelines.
- Knowledge and experience in Risk Management principles.
- Knowledge in both clinical and commercial product desired.
- Strong Management and process improvement skills.
- Demonstrate excellent verbal, written, and interpersonal communication skills.
- Demonstrate experience leading and contributing through influence and working in cross functional teams.
- Comprehensive knowledge of biologics manufacturing.
- Experience with vaccine manufacturing operations preferred.
- Experience in commercial launch desired.
- Experience with overseeing GMP manufacturing in a commercial facility.
- Fluency in spoken and written English.
- Positive, proactive approach to complex quality issue.
Reports to: Executive Director, Quality Assurance
Location: Visp, Switzerland
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Send resumes to:
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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