The Position

re you ready to make a real difference in patients’ lives and thrive in a fast-paced team-oriented environment? At Maze Therapeutics, we’re on a mission to revolutionize healthcare through the power of human genetics, and we’re looking for a highly motivated Associate Director of Clinical Quality Assurance (QA) to join our team. In this pivotal role, you’ll ensure the quality and compliance of our clinical development pipeline and studies. Reporting to the Director of QA, you’ll have a direct impact on the success of our clinical programs and the design of the Maze Good Clinical Practice (GCP) compliance program. You will identify and escalate compliance issues, enable decision-making, and drive the development and execution of effective and comprehensive action plans to mitigate clinical quality and compliance risks. Additionally, you will lead the development and management of our quality management system providing oversight related to GCP activities while representing Quality on Clinical Development teams.

The Impact You’ll Have

• Partner and develop strong relationships with Clinical Operations and Clinical Sciences personnel across development teams and provide coaching and strategic compliance guidance.
• Serve as the Clinical Quality lead on clinical study teams and provide leadership and direction to Clinical Operations and Development stakeholders on GCP related activities/issues.
• Act as a GCP expert and consultant for Clinical Operations colleagues.
• Collaborate with stakeholders to assess clinical trial risks, identify study priorities, track compliance metrics, identify high-risk vendors, and define key compliance activities.
• Develop and maintain relationships with CRO Quality teams to ensure ongoing review of quality and compliance issues.
• Support vendor management, evaluation, and qualification of GCP service providers.
• Implement and support Maze Quality Systems and Cross functional SOP development, and lead quality clinical study oversight processes.
• Understand organizational changing needs, and complete ongoing gap analyses, enable process development, and lead best practice opportunities inclusive of standard operating procedures (SOP’s), and templates to be consistent with current ICH/GCP principles.
• Identify and escalate significant quality and compliance issues to the Head of Clinical Operations and Head of Quality Assurance.
• Provide guidance and support during and following internal audits and external regulatory inspections.
• Lead inspection readiness activities in Clinical Development.
• Conduct training sessions for Maze staff, as needed.

As an Associate Director, we also expect you to demonstrate the following Leadership Competencies:

• Communication and Influence
  • Builds communication channels across Maze for sharing information
  • Influences Senior Management decisions through persuasive arguments
  • Respectfully addresses differing opinions leading to support of decision
• Teamwork and Collaboration
  • Champions partnerships and connections across Maze
  • Proactively addresses issues that could result in breakdown of team relationships
  • Spotlights team and individual contributions in public forums
• Execution and Results
  • Addresses gaps and leverages strengths to get best results
  • Maintains a steadying presence and clarifies priorities during change
  • Anticipates and removes barriers that put functional/corporate goals at risk
• Develop Others and Self
  • Removes barriers to staff development and empowers them to make their own decisions
  • Stays current on industry trends and keeps direct reports prepared and responsive

What We’re Looking For

• Bachelor’s degree in a scientific discipline with 8 + years of relevant experience in pharmaceutical quality assurance and compliance.
• Proven expertise in implementing and managing quality systems.
• Thorough knowledge and understanding of drug development and the clinical trial process.
• In-depth knowledge of current regulatory and ICH GCP requirements, with experience in international regulations, guidelines, and standards. (GLP knowledge is a plus).
• Ability to engage and influence key stakeholders at all levels to drive compliance and quality outcomes.
• Exceptional attention to detail, with the ability to work independently, within cross-functional teams, and alongside external partners and vendors.
• Ability to set priorities, manage timelines, work with minimal supervision in a fast-paced environment.
• Willingness to travel for critical on-site activities and relevant QA or vendor oversight activities.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team- first mentality, we’ll achieve our mission.

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $187,000 to $229,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.