Sr. Manager, Clinical Quality Assurance

The key responsibilities of the Senior Manager, Clinical Quality Assurance at Vaxcyte include leading global investigations and supporting teams with CAPA preparation to ensure compliance with regulatory requirements. You will manage quality issues and serious breaches, review investigations and root cause analyses, and track quality events from audits and inspections until closure. Additionally, you will evaluate policies for compliance and promote a culture of quality excellence.

To qualify for the Senior Manager, Clinical Quality Assurance position at Vaxcyte, candidates should have a BA or BS in a related field, along with a minimum of 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry. Knowledge of quality management systems, particularly Veeva, is preferred, as well as a GCP QA Certification. Familiarity with FDA regulations and ICH guidelines is also essential for success in this role.

Vaxcyte ensures compliance within the Clinical Quality Assurance role through diligent oversight of quality management processes. The Senior Manager will be responsible for leading investigations, managing quality issues, and ensuring that corrective actions are effectively implemented. Through regular reviews of policies and adherence to regulatory standards, Vaxcyte promotes a quality-first mindset across all operations.

The work culture for a Senior Manager, Clinical Quality Assurance at Vaxcyte is collaborative and supportive. Vaxcyte embodies a kindness-first approach in leading teams, encouraging open communication and vigorous debate. The company promotes innovation by embracing creative diversity in problem-solving and aims high in its mission to develop complex biologics, making it an exciting place for professionals passionate about quality in healthcare.

For the Senior Manager, Clinical Quality Assurance at Vaxcyte, there are substantial career progression opportunities. By demonstrating excellence in quality management and compliance, there may be pathways to take on even more senior leadership roles within the quality assurance department or broader project management positions. Continuous professional development is encouraged, with access to training and opportunities to lead impactful quality initiatives.

When answering this question, highlight specific experiences with quality management systems you've worked within, detailing the software used and how you ensured compliance with regulations. Provide examples of challenges faced and how you overcame them, showcasing your analytical and problem-solving skills.

Discuss your systematic approach to identifying, analyzing, and resolving quality issues. Stress the importance of collaboration with other departments, using CAPA processes effectively, and the role of communication in addressing quality concerns. Providing a concise case study from your past experience can be helpful.

Explain your commitment to continuous learning and professional development. Mention specific resources such as industry journals, webinars, and professional networks that you follow. This demonstrates your proactive approach to staying compliant and informed in your role as a Senior Manager in Clinical Quality Assurance.

Discuss techniques you employ to instill a quality-first culture among your colleagues, such as regular training sessions, open discussions about quality standards, and recognition of excellence. Share examples of how you've successfully motivated teams to adopt a quality mindset in past roles.

Identify key challenges such as ensuring compliance amidst evolving guidelines or managing cross-functional team dynamics. Discuss how you've effectively navigated these challenges in the past, emphasizing your problem-solving abilities and leadership style.

Share your direct involvement in conducting root cause analyses and implementing CAPAs. Highlight a specific instance where your analyses led to substantial improvements and adherence to quality standards, detailing steps taken and results achieved.

Outline a structured approach to managing breaches, including immediate containment measures, thorough investigation processes, and collaboration with appropriate stakeholders. Emphasize the need for transparency and adherence to regulatory guidance in your response.

Provide a detailed illustration of a process improvement initiative, outlining the problem it aimed to address, steps taken for implementation, and metrics used to measure success. Highlight collaboration with your team to foster engagement and ownership of the new processes.

In your response, mention specific tools you've found effective, linking back to how they improve efficiencies in managing quality assurance processes. Discuss the importance of choosing tools that integrate well with existing systems, such as Veeva if applicable.

Discuss the importance of clear, concise, and transparent communication when interacting with regulatory bodies. Share strategies you employ, such as thorough documentation, timely responses to inquiries, and proactive engagement in discussions to ensure compliance and maintain positive relationships.