Director, Quality

Director, Quality

Step into a pivotal role where science meets strategy. At Maze, we're on a mission to uncover genetic insights and transform them into precision medicines that change lives. Our team is driven by curiosity, collaboration, and a commitment to improving treatment for people with severe diseases. We thrive on diverse perspectives and bold ideas, and we're looking for someone who shares that spirit.

As our Director of Quality, you'll shape and lead the Quality function at Maze, guiding strategy, systems, and compliance across our development programs. You'll be instrumental in evolving our GxP processes and ensuring we're inspection ready as we move into Phase 2 and beyond, with a focus on robust vendor oversight and building scalable systems to support late-stage and future commercial success.

Reporting to the Vice President of Regulatory and Quality Science, you'll manage and develop two direct reports and foster a culture of collaboration, accountability, and continuous learning that extends across the organization.

The Impact You'll Have

• Be accountable for and evolve Maze's GxP Quality strategy, providing leadership across internal operations and external partners.
• Develop and implement risk-based Quality approaches for investigational materials, ensuring phase-appropriate systems from early development through commercialization.
• Lead the development and continuous improvement of Quality Systems and SOPs supporting GxP activities.
• Provide Quality oversight and input for regulatory submissions and correspondence, including INDs, IMPDs, CTAs, and interactions with FDA and global health authorities.
• Partner strategically with CMC and lead GMP vendor oversight to ensure manufacturing, testing, packaging, labeling, and distribution activities comply with cGMP, FDA, ICH, EMA, and industry standards.
• Lead QA investigations, including product-impacting issues, and provide oversight and approval of CAPAs from deviations, complaints, recalls, audits, and inspections, ensuring timely and effective resolution and closure of findings.
• Drive Maze's inspection readiness and serve as the lead Quality representative during health authority inspections.
• Represent QA on cross-functional teams and company initiatives, providing Quality leadership and guidance in decision-making.
• Stay current on evolving global regulations and industry best practices related to GxP and compliance, and apply these insights to strengthen Maze's Quality frameworks and systems.
• Develop and deliver GxP training across Maze, identifying opportunities for continuous improvement and embedding industry best practices into daily operations.
• Oversee Document Control systems, ensuring compliance, consistency, and effective lifecycle management of Quality records.

As a Director, we also expect our leaders to demonstrate the following Leadership Competencies :

Role models clear communication and open two-way conversations.

Champions collaborations and connections across Maze.

Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success.

Develops staff capabilities to handle delegation of responsibilities.

What We're Looking For

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 $212,000 - $258,000. 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.