Job Details

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

• Demonstrates strong knowledge of global GxP expectations, regulations, and quality trends across the product development lifecycle – bench to bedside.
• Demonstrates the ability to organize, sequence tasks per priority, delegate, thrive in a fast-paced, deadline driven environment, and communicate meaningful expectations.
• Develops key quality metrics, including quality system, process, and people metrics, that provides insights and foresights in identifying and addressing quality systems or product concerns or opportunities.
• Exhibits strong interpersonal skills, with experience in leading high-performance team and cross functional projects including a successful track record working with senior management and other key stakeholders.
• Establishes effective escalation paths that communicates a current context and then a proactive, evidence-based solution while calibrating management and supplier awareness and action.
• Demonstrates a goal orientation with a completion mindset that incorporates the ability to troubleshoot, resolve problems, and learn from and then share the learning with others.
• Advocates continuous improvement to quality processes, well-trained workforce, streamlined business processes, and appropriately structured quality operations.
• Demonstrates a self-organizing orientation that leverages minimal supervision, constructs priorities and deadlines based on the needs of the business and quality requirements and motivates and influences others.
• Recruits, develops, trains, mentors, coaches, and counsels team members for success and high performance.
• Be willing to travel 5% of the time.

ALUMIS VALUES

• We Nurture

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:

• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient's lives-- and we aspire toelevate,challengeandnurtureone another along the way.

*Lab personnel are generally onsite 4-5 days/week.

Create a Job Alert

Interested in building your career at Alumis? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

LinkedIn Profile

Do you (now or in the future) require authorization to work in the US? * Select...

Street Address: *

Address Line 2: *

City: *

State: *

Country: *

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Alumis's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Voluntary Self-Identification of Disability

Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

• Alcohol or other substance use disorder (not currently using drugs illegally)
• Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
• Blind or low vision
• Cancer (past or present)
• Cardiovascular or heart disease
• Celiac disease
• Cerebral palsy
• Deaf or serious difficulty hearing
• Diabetes
• Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
• Epilepsy or other seizure disorder
• Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
• Intellectual or developmental disability
• Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
• Missing limbs or partially missing limbs
• Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
• Nervous system condition, for example, migraine headaches, Parkinson's disease, multiple sclerosis (MS)
• Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
• Partial or complete paralysis (any cause)
• Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
• Short stature (dwarfism)
• Traumatic brain injury

Disability Status Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

#J-18808-Ljbffr