Manager, Quality Assurance, Product Complaint

The Manager, Quality Assurance, Product Complaint at Eidos Therapeutics is responsible for managing product quality complaints related to both commercial marketed products and clinical trial materials. This includes maintaining global processes for complaint handling, conducting investigations, managing timely complaint closures, and ensuring all complaints comply with regulatory standards and internal procedures.

Candidates for the Manager, Quality Assurance, Product Complaint role at Eidos Therapeutics should have a Bachelor’s degree in operations, science, mathematics, or engineering, alongside a minimum of 5 years of experience in the biotech or pharmaceutical field, specifically in a regulatory QA environment. Familiarity with quality management systems and global product complaint handling guidelines is essential for this position.

Eidos Therapeutics ensures compliance within its Quality Assurance department through rigorous process management, regular audits, and adherence to established regulatory standards. The Manager, Quality Assurance, Product Complaint will work with cross-functional teams to establish effective investigation strategies and corrective actions that align with internal and external quality expectations.

The work culture at Eidos Therapeutics is dynamic and collaborative, emphasizing patient-first values and scientific excellence. As a Manager in Quality Assurance, you’ll find an environment that encourages independent thinking, transparency, and rapid execution. The company promotes a decentralized model empowering teams to make decisions that directly impact patient care and product quality.

Eidos Therapeutics offers rapid career advancement opportunities for strong performers in the Manager, Quality Assurance, Product Complaint position. Employees are encouraged to take ownership of their career paths and may have the chance to contribute to multiple programs across different therapeutic areas, enhancing professional growth within a collaborative and innovative environment.

When answering this question, provide specific examples of your past roles in handling product complaints. Discuss the steps you took in investigating, documenting, and resolving complaints, and how you ensured compliance with regulatory requirements. Highlight your knowledge of FDA and global guidelines and your ability to work across teams for successful outcomes.

It's important to share your approach to prioritization, focusing on urgency and regulatory timelines. Discuss tools or methods you utilize for effective task management, such as metrics tracking, which helps identify high-impact complaints that require immediate action alongside regular reporting procedures.

Provide a clear scenario where you identified a quality issue and the specific actions you took to address it. Detail your analytical approach and the collaboration with subject matter experts to resolve the issue while implementing corrective actions that prevented recurrence.

Discuss the importance of clear communication, mutual respect, and established protocols for collaboration. Emphasize the need for understanding each department's goals and how they align with the overall mission of ensuring product quality. Provide examples of past experiences where collaboration led to positive outcomes.

Highlight your strategies for knowledge transfer, which may include developing training materials, providing hands-on guidance, and instilling an understanding of compliance culture. Emphasize the importance of integrating new team members into ongoing projects to help them learn in a real-world context.

Mention specific tools like eQMS, Microsoft Office, or other quality management systems you have experience with. Explain how you leverage these tools for efficient tracking and reporting of quality issues, ensuring all team members are trained and informed on best practices regarding their use.

Provide examples of your involvement in preparing for and participating in audits or inspections. Detail the steps you took to ensure compliance, such as documentation reviews, employee training sessions, and process evaluations to demonstrate your readiness to handle regulatory scrutiny.

Discuss the resources you utilize, such as industry publications, professional networks, and attending workshops or webinars. Mention how you proactively share relevant updates with your team to ensure compliance and continuous improvement.

Outline your analytical approach with data collection methods, use of statistical tools, and what metrics you focus on when identifying trends in complaints. Discuss how this analysis informs corrective actions and shapes product quality strategies.

Express your understanding that every decision made in quality assurance directly impacts patient safety and product efficacy. Discuss how a commitment to patient-first values motivates the work you do and shapes the culture within the quality assurance team, ultimately striving for excellence in all processes.