Associate Director, Clinical Quality Assurance

6 days ago

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $172k - $201k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Vaxcyte

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Vaxcyte is a biotechnology company focused on developing innovative vaccines to combat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Utilizing advanced chemistry and synthetic techniques, Vaxcyte aims to improve upon existing vaccines with products like their VAX-24 and VAX-31 pneumococcal conjugate vaccines, which target a broad range of bacterial strains. Vaxcyte's approach includes re-engineering the vaccine-making process through the XpressCF™ cell-free protein synthesis platform, aiming to create vaccines that effectively counter bacteria's complex defense mechanisms while maintaining immunogenicity. Their pipeline includes several high-fidelity, broad-spectrum vaccine candidates designed to address significant public health challenges and prevent bacterial infections worldwide.

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• 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... • WHAT we do is every bit as important as HOW we do it! • Our work together is guided by four enduring core values: • RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do... • AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics... • LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach... • MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment... • We are seeking a dedicated and experienced Associate Director, Clinical Quality Assurance, to join our dynamic team...

🎯 Requirements

• BA or BS in related field. • Minimum of 10 years of experience in Quality Assurance within the clinical or pharmaceutical industry. • Experience in oversight of Phase III vaccine trials • Demonstrate in-depth knowledge of GCPs, FDA and EU requirements and ICH guidelines. • Experience across all phases of clinical development. • Strong project management skills with the ability to manage multiple projects simultaneously. • Demonstrate ability to oversee assigned QA team. • GCP QA Certification preferred (RQAP-GCP, or similar). • Proficiency in QA tools and software (Veeva preferred). • Excellent communication and interpersonal skills, with the ability to work collaboratively with diverse teams. • Strong analytical and problem-solving skills, with a keen attention to detail. • Strong sense of ownership in areas of responsibility.