Quality Manager

As a Quality Manager at Compass Pathways, you will oversee the Quality Management System (QMS) and ensure effective quality operations across the organization. This includes measuring and monitoring performance through KPIs, managing the audit program, generating regular reports for the Quality Council, and being a MasterControl superuser. You will also support cross-functional quality culture initiatives and lead investigations into significant quality issues by developing appropriate corrective and preventive actions.

To be considered for the Quality Manager role at Compass Pathways, you should possess a Bachelor's degree in a scientific discipline or a combination of education and experience that is equivalent. It's also vital to have substantial QA experience in a GMP and/or GCP biotech or pharmaceutical setting, along with demonstrated auditing experience across all GxP areas, particularly Good Clinical Practice (GCP). Excellent interpersonal skills and knowledge of FDA and EMA regulations are essential for this role.

At Compass Pathways, the audit program for the Quality Manager involves overseeing and coordinating audits across the organization to ensure compliance with established quality standards and regulations. You will be responsible for reviewing audit reports for consistency, tracking auditor qualifications, and managing contracts and agreements with auditors. This crucial aspect of the role helps maintain the integrity and quality of our operations, ultimately contributing to improved patient outcomes.

The Quality Manager at Compass Pathways plays a pivotal role in fostering a quality culture by engaging with cross-functional teams to promote best practices and shared accountability. You will work collaboratively with other departments to implement quality initiatives and facilitate training processes. By being a quality subject matter expert, you will also help create training packages and process designs that encourage an organizational commitment to quality and continuous improvement.

As a Quality Manager at Compass Pathways, you will enjoy a flexible working environment whether you choose to work remotely or from our London office. You'll also benefit from a comprehensive compensation package that is reflective of your skills and experience, and you will be part of a mission-driven organization that's dedicated to improving mental health treatment. Additionally, our commitment to diversity and equality creates an inclusive workplace where everyone's contributions are valued.

When answering this question, highlight your familiarity with various QMS frameworks and your specific experiences managing them in previous roles. Mention any relevant certifications you've obtained, and outline the systems you've implemented or improved. Be sure to connect your skills to how they can contribute to Compass Pathways’ goals.

Explain your systematic approach to auditing, including planning, conducting interviews, reviewing documentation, and reporting findings. Mention any particular methodologies you prefer and how you engage team members during the audit process to foster a collaborative environment. Tie your answer to the importance of maintaining quality standards at Compass Pathways.

Discuss your understanding of the regulations and how you remain updated on changes or updates. Provide examples of specific instances where you've successfully ensured compliance, particularly in relation to documenting processes or training staff. Relate this back to how these practices can support the mission of Compass Pathways.

Share a specific example that demonstrates your problem-solving skills and ability to implement corrective and preventive actions. Describe the situation, your role in addressing it, and the outcomes. Emphasize your investigative approach and how this experience will benefit your role as Quality Manager at Compass Pathways.

Talk about the importance of open communication in maintaining quality standards and how you actively promote this within teams. Share specific strategies you have used to encourage dialogue and collaboration, such as regular quality meetings or feedback loops, and how they can enhance the quality culture at Compass Pathways.

Discuss the tools and software you use for tracking quality metrics and how you develop meaningful reports for various stakeholders. Explain how you prioritize the metrics that matter most to your organization and how you communicate them clearly to drive quality initiatives. Relate this back to providing valuable insights for Compass Pathways.

Explain your approach to process improvement, including any methodologies you employ (e.g., Lean principles). Discuss how you've implemented changes in previous roles, measured their effectiveness, and how you would apply this knowledge as Quality Manager at Compass Pathways. Highlight your results-oriented approach.

Describe your approach to conflict resolution, focusing on diplomacy and understanding different viewpoints. Include examples of how you facilitated resolution in past experiences, emphasizing a collaborative approach to fostering quality objectives at Compass Pathways.

Mention specific resources you rely on, such as industry journals, online courses, or professional associations. Highlight your commitment to continuous learning and how this can directly impact your effectiveness as a Quality Manager at Compass Pathways.

Explain the significance of training and development in imbibing a quality-first mindset throughout the organization. Share examples of training programs you’ve developed or participated in and how you would implement similar initiatives for staff at Compass Pathways to uphold quality standards.