Senior Director, Clinical Quality Assurance

South San Francisco

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. 

Alumis is hiring a Clinical Quality Assurance Sr. Director, reporting to the SVP of Quality. The role will work closely with the Development leadership and Study Execution Team members to provide GCP/GVP support for all ongoing clinical studies. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis.

The Clinical QA Sr. Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools and risk mitigations. The Sr. Director will be responsible to establish Key Performance Indicators and Metrics to trend and track the health of the clinical trials. The role is responsible for providing operational quality guidance for the development teams and supporting the VP of Quality in building the Alumis Quality organization strategy and vision.

This position requires expertise in Good Clinical and Pharmacovigilance Practices (GCP & GVP) and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management.  The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities. 


Essential Duties & Responsibilties

  • Establish and maintain the GCP QA programs, policies, and procedures.
  • Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines.
  • Act as the primary GCP QA subject matter expert and point of contact for all GCP/GVP related matters and issues.
  • Establish the study-specific audit plan; perform audits and lead a team of external quality auditors as needed.
  • Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings.
  • Manage Quality Review Board meetings content and material. Prepare KPI and metrics.
  • Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
  • Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues.
  • Determine the strategy for and lead the implementation of inspection readiness plans and activities. Act as the primary liaison with the Health Authority and internal/external business partners.
  • Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.

Education & Experience

  • Bachelors or advanced degree in Biology, Chemistry, or related field.
  • Minimum 12 years of GCP/GVP Quality Assurance experience.
  • Strong understanding of small molecule products with direct experience in solid oral dosage forms.


Knowledge | Skills | Abilities

  • Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
  • Hands-on experience in drug life cycle management.
  • A successful track record of working with service providers and CROs.
  • Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
  • Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
  • Excellent verbal and written communication skills.
  • Collaborative, analytical and interpretative skills.
  • Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.
  • Previous experience in successfully leading assigned activities within cross-functional teams.
  • Some travel is required.

 

The salary range for this position is $260,000 USD to $275,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.   

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday.*  At this time we are not considering remote applicants.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.  

Other benefits include:

  • Health insurance premiums paid at 90% for employee, 80% for dependents
  • 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 to elevate, challenge and nurture one another along the way.

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

Apply for this job

*

indicates a required field

Resume/CV*

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

Cover Letter

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

Select...

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 hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential 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.

Select...
Select...
Race & Ethnicity Definitions

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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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

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
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.