Senior Director Quality Intelligence and Systems

Senior Director Quality Intelligence and Systems

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

Sr. Director, Quality Intelligence and Systems is a role reporting to the Senior Vice President of Quality and Regulatory. The Sr. Director is responsible for optimizing quality systems and their management to fulfill the purpose of detection, maintenance, and correction of the underlying quality process of interest (e.g., documentation, training / qualification, deviation, CAPA, change control, supplier management, product complaints). This role interprets, integrates, and applies compliance signals to ensure adherence informed by the latest quality regulations, guidance, or expectations.

This position requires extensive expertise in the GxPs and relevant regulations. The successful candidate drives, promotes, and embeds a culture of ethics, integrity, and proactive quality management. The candidate provides support to ensure that the quality function maintains the standards expected by health authorities and facilitates “Right-First-Time” and phase-appropriate decisions through risk and knowledge management processes.

Essential Duties & Responsibilities

• Partner closely with the SVP, Quality and Regulatory to drive execution of strategic priorities and departmental planning.
• Oversee and manage the Quality Systems group, including document control, training, quality supplier management, deviation, CAPA, and change control, maintaining content and execution ownership with the functional areas.
• Oversee the global Quality Systems strategy, integrating data, insights, and compliance signals to enable proactive, risk-based decision-making.
• Lead and align cross-functional initiatives that advance quality system maturity, inspection readiness, and operational excellence.
• Act as a strategic liaison between the Quality Systems function and the business.
• Lead Quality Governance processes (QSMR, SOGO, ITQuality, etc.) that elevate enterprise visibility and support a high-performing quality culture.
• Lead development and tracking of Quality KPIs to measure performance and support continuous improvement.
• Act as the “Chief of Staff” for the Quality team. Facilitate the operating rhythm of the Quality leadership team, ensuring alignment and follow-through on key decisions.
• Develop and maintain a comprehensive knowledge of compliance signals that inform strategic quality decisions and initiatives.
• Bridge quality insights into actionable strategies to ensure the company remains at the forefront of industry compliance and quality standards.
• Drive continuous improvement initiatives based on quality trends and intelligence.
• Develop and implement quality strategies and systems that integrate quality intelligence to enhance compliance and operational efficiency.
• Collaborate with cross-functional teams to ensure alignment of quality objectives and act as a liaison with suppliers to address quality systems issues.
• Author, review, or approve appropriate quality documents including SOPs, quality systems records, and health authority responses.
• Promote a culture of proactive quality management and health authority compliance, guiding quality mindset and excellence across the organization.
• Use data to recognize trends, shape strategy, and inform activities using dashboards and other communication vehicles.

Education & Experience

Knowledge / Skills / Abilities

ALUMIS VALUES

This position is located in South San Francisco, CA. At this time, we are not considering remote applicants.

Alumis Inc. is an equal opportunity employer. If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID-19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated.

The salary range for this position is $236,000-$295,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.

Other Benefits Include

We are a hard-working, collaborative team on a mission to transform patients’ lives—and we aspire to elevate, challenge and nurture one another along the way.

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