Quality Operations Manager

As the Quality Operations Manager at Legend Biotech, you'll be responsible for providing quality oversight in personalized cell therapy production, supervising Quality Assurance personnel on the shop floor, and collaborating with various departments to troubleshoot operations. Your role will also include ensuring compliance with GMP standards, developing improvement initiatives, and supporting audits to maintain the highest quality for our products.

To qualify for the Quality Operations Manager position at Legend Biotech, candidates need a Bachelor's Degree in Science or a related field and a minimum of 6 years of relevant experience in an aseptic manufacturing environment. Leadership experience, preferably 1 year, along with knowledge of cGMP, FDA regulations, and experience in Quality Assurance or cell therapy, is highly desirable for this role.

Essential skills for the Quality Operations Manager role at Legend Biotech include strong interpersonal and communication abilities, problem-solving skills, and a detail-oriented nature. The ability to process complex information quickly, work effectively in a fast-paced environment, and manage multiple priorities while demonstrating leadership and project management skills are crucial for success.

Career growth for a Quality Operations Manager at Legend Biotech can be substantial. As you gain experience and expertise, you may have opportunities to lead larger teams, engage in more complex project management, or move into higher leadership roles within the Quality department as our company continues to innovate in cell therapy and personalized medicine.

The daily work environment for the Quality Operations Manager at Legend Biotech involves a dynamic atmosphere where collaboration is key. You'll work closely with various teams, overseeing production processes while ensuring compliance with quality standards. Your role requires adaptability as you’ll address various challenges and contribute to continuous improvement efforts, all within a supportive and inclusive team culture.

When answering this question, emphasize your knowledge and practical experience with Good Manufacturing Practices (GMP). Discuss specific instances where you ensured compliance, resolved issues related to GMP regulations, and how your efforts contributed to maintaining product quality.

To address this question, outline your approach to prioritization, such as using task lists, deadlines, and urgency of issues. Share an example of a situation where you successfully managed competing priorities while ensuring quality standards were met, showcasing your organizational skills.

In your response, describe a specific quality issue you encountered, detailing the steps you took to investigate, assess its impact, and implement a solution. Highlight your analytical skills and collaboration with cross-functional teams to demonstrate your ability to handle challenges effectively.

Discuss different strategies such as building strong relationships, effective communication, and providing data-driven insights. Share an example where your influencing skills led to positive changes in quality processes or improved operational outcomes.

Show your proactive approach to staying informed. Mention sources such as industry publications, conferences, webinars, and professional networks. Discuss how you integrate this knowledge into your daily work and decision-making processes.

Be specific about any tools you have used, like Six Sigma or Lean methodologies, and explain how you have applied them in your previous roles to drive process improvements, optimize workflows, or enhance quality outcomes.

Discuss the importance of regular check-ins, team meetings, and open feedback channels. Provide examples of how you have fostered a communicative team environment where everyone feels valued and heard, contributing to improved performance.

Explain your approach to training and mentoring, focusing on structured onboarding processes, hands-on guidance, and fostering a supportive atmosphere. Share specific examples of how your mentorship has enhanced the skills of new team members.

When answering, outline the situation that required a CAPA response, the investigation process you followed, and the actions taken. Emphasize the outcomes and how these actions improved quality control and operational efficiency.

Provide an overview of your auditing experience, discussing types of audits conducted, your role in the process, and how audit findings have been used to improve compliance and quality standards within the organization.