Associate Director, Clinical Quality Assurance

As an Associate Director of Clinical Quality Assurance at Vaxcyte, you will lead the quality oversight of our Adult Phase III Vaccine Program, providing essential guidance to the Clinical Operations team across various trials. You will also manage a team dedicated to this program, identifying potential risks in study design and execution, and implementing strategies to mitigate quality issues. Your role includes evaluating compliance with regulations and recommending process enhancements, ensuring inspection readiness, and promoting a culture of quality excellence throughout the organization.

To qualify for the Associate Director of Clinical Quality Assurance at Vaxcyte, candidates should hold a BA or BS in a related field and possess a minimum of 10 years of experience in Quality Assurance within the clinical or pharmaceutical sectors. It is essential to have oversight experience in Phase III vaccine trials and a strong understanding of GCPs, FDA and EU requirements, and ICH guidelines. Strong project management abilities and proficiency in QA tools, particularly Veeva, are also important. A GCP QA Certification (like RQAP-GCP) is preferred.

At Vaxcyte, promoting a quality mindset is integral to our success. As the Associate Director of Clinical Quality Assurance, you will lead by example and instill a culture where quality and excellence are paramount in all activities. Your work will involve guiding teams on regulatory compliance and the best practices in quality assurance while supporting initiatives aimed at continuous improvement. The collaborative and inclusive work environment will allow you to engage with diverse teams and foster a proactive approach to quality that aligns with our core values.

The salary range for the Associate Director of Clinical Quality Assurance at Vaxcyte is competitive, falling between $172,000 and $201,000, specifically for the San Francisco Bay Area. Please note that salary ranges may vary for candidates in non-California locations. Alongside a competitive salary, Vaxcyte offers a comprehensive benefits package and equity components, making this an attractive opportunity for skilled professionals in the field.

Vaxcyte is committed to being an equal opportunity employer, and we believe that diversity and inclusion enhance our workplace and drive innovation. In the Associate Director of Clinical Quality Assurance role, candidates can expect a supportive environment where every qualified applicant is considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. We value the unique perspectives and experiences of our employees and strive to create an inclusive culture that welcomes diverse talent.

To answer this question effectively, discuss your previous work on Phase III trials, including your specific responsibilities and any challenges you faced. Highlight how you ensured compliance with GCPs and contributed to the overall success of the trials. Being specific about your role and outcomes can demonstrate your impact and expertise in this area.

When asked about risk management, provide examples of how you've identified potential risks in study designs and what strategies you implemented to mitigate those risks. Discuss your collaborative efforts with teams and subject-matter experts, emphasizing your analytical skills and proactive approach to maintaining quality standards.

In your response, list any QA tools and software you are proficient in, particularly mentioning Veeva if applicable. Explain how you have used these tools to manage quality processes, track compliance, and improve efficiency within your previous roles.

To answer this question, share a relevant scenario where you led a team to overcome a quality issue. Focus on how you guided your team, the steps you took to resolve the problem, and the outcome. Highlight your leadership style and how you promote a quality-first approach in your team dynamics.

In responding, define GCP and discuss its critical role in ensuring the integrity of clinical trials and the safety of participants. Share how you have applied GCP principles in your work and any experience you have with audits or inspections related to GCP compliance.

Detail the resources you utilize to stay informed about current regulatory changes, such as industry journals, webinars, and professional networks. Discuss how continuously updating your knowledge has helped you maintain compliance and adapt quality assurance processes effectively.

When discussing collaboration, emphasize specific approaches you take to foster an inclusive environment. Mention strategies like facilitating open dialogue, encouraging input from all team members, and utilizing team-building activities that promote teamwork and understanding across diverse backgrounds.

In your response, detail a specific instance where you identified an area for improvement in a QA process. Explain your approach to analyzing the situation, the recommendations you made, and the results of implementing those changes, focusing on how it enhanced the overall quality landscape.

Share what drives you in the quality assurance field, such as your commitment to patient safety, the pursuit of excellence, and the desire to contribute to impactful clinical outcomes. Discuss how this motivation influences your daily work and decision-making processes.

Identify contemporary challenges like evolving regulatory landscapes, maintaining compliance in a dynamic environment, and the integration of new technologies. Offer insights on how you would address these challenges based on your experience and understanding of the industry.