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Associate Director, Clinical Quality Assurance
San Carlos, California, United States
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:
*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.
*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.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
We are seeking a dedicated and experienced Associate Director, Clinical Quality Assurance, to join our dynamic team. The ideal candidate will have a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence. This role requires an individual who can work with teams to ensure compliance with regulatory requirements and achieve our mission of delivering high quality healthcare solutions.
Essential Functions:
- Lead quality oversight of Adult Phase III Vaccine Program.
- Provide guidance to Clinical Operations team on multiple Phase III trials.
- Manage a team of 1-4 QA employees dedicated to the Adult Vaccine Program.
- Identify potential risk associated with study design / execution and collaborate with subject matter experts to implement mitigation strategies to minimize quality issues.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Provide Clinical Quality Assurance updates to Clinical Operations, and Clinical Operations updates to upper QA Management.
- Support Inspection Readiness activities for Vaxcyte, Clinical Sites and Clinical Service Providers.
- Support in QA initiatives/projects for quality, process improvements.
- Promotes a quality mindset and quality excellence approach to all activities.
- Understands and interprets regulatory agencies policies and guidance as it pertains to GCP requirements and assists in the implementation of compliant processes at Vaxcyte.
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.
Reports to: Director, Clinical Quality Assurance
Location: San Carlos, CA; Open to remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $172,000 – $201,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Relocation:
This role is eligible for relocation assistance.
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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