Director/ 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

Alumis is hiring a forward-thinking Director of Quality Intelligence and Systems reporting to the Senior Vice President of Quality and Regulatory.  The Sr. Director is responsible to optimize quality systems and its 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). In addition, this role interprets, integrates, and applies compliance signals to ensure compliance adherence that is 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 the 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 but not limited to 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, foster a right-first-time mindset, 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.
• Drives 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.
• Collaborates with cross-functional teams to ensure alignment of quality objectives and acts 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 ensuring quality mindset and quality excellence approach throughout the organization.
• Uses data to recognize trends, shape strategy, and inform activities using dashboards and other communication vehicles.

EDUCATION & EXPERIENCE

• Bachelor’s degree, advanced degree preferred, in a scientific discipline, communication, business, or training with a minimum of 12 years of industry experience, including relevant combination of education, experience, or training in GxP, quality assurance, quality intelligence, or Life Sciences.
• Five (7) plus years of management experience leading teams and influencing stakeholders internal and external.
• Experience in implementing and managing electronic quality management systems (eQMS), including document management, and learning management systems.
• Experience interacting with health authorities through supporting inspection with on demand evidence fulfillment or interaction with the investigator, and/or writing responses to findings/observation.
• Familiarity with the Quality Management Maturity Model.
• Experience with an emerging virtual company.

KNOWLEDGE/ SKILLS/ ABILITIES