Director, Clinical Quality Assurance

2 weeks ago

South San Francisco, United States Alumis Full time
Job DescriptionJob DescriptionSalary:

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 Director, reporting to the Sr. Director GCPQA. The role works closely with the Quality leadership and Study Execution Team members to provide ICH-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 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 Director will be responsible to establish Key Performance Indicators and Metrics to trend and track on the health of the clinical trials. 

 

The role is responsible for providing operational quality guidance for the development teams and supporting the Sr. Director of GCP Quality in building the Alumis Quality organization strategy and vision.  

 

This position requires expertise in Good Clinical and Pharmacovigilance Practices (ICH-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 ICH-GCP Clinical QA programs, policies, and procedures.  
  • Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines. 
  • Act as the primary ICH-GCP Clinical QA subject matter expert and point of contact for all ICH-GCP/GVP related matters and issues for the assigned studies and initiatives.  
  • 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 Clinical QA to Clinical  QA meetings. 
  • 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. 
  • Support inspection readiness plans and activities. Act as the primary liaison with Health Authority and internal/external business partners for the assigned studies and programs. 
  • 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 ICH-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, to motivate and influence others. Prior management experience is required. 
  • Previous experience in successfully leading assigned activities within cross-functional teams. 
  • Some travel required.  

 

Alumis Values 

 

  • Elevate 
  • Challenge 
  • Nurture 

 

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

 

The salary range for this position is $220,000 – $230,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices. 

 

Alumis Inc. is an equal opportunity employer. 

  • Director, Clinical Quality Assurance

    3 weeks ago

    South San Francisco, United States Alumis Inc. Full time

    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...

  • Director, Clinical Quality Assurance

    6 days ago

    South San Francisco, United States Alumis Inc. Full time

    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...

  • Director, Clinical Quality Assurance

    6 days ago

    South San Francisco, California, United States Alumis Inc. Full time

    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...

  • Director, Clinical Quality Assurance

    3 weeks ago

    South San Francisco, California, United States Alumis Inc. Full time

    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...

  • Director, Clinical Quality Assurance

    1 month ago

    South San Francisco, California, United States Alumis Inc. Full time

    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...

  • Director/Senior Director, Clinical Quality Assurance

    7 days ago

    South San Francisco, United States Annexon Full time

    Work Location Corporate Headquarters (South San Francisco, CA) – Hybrid Position Summary Annexon Biosciences seeks a Quality Assurance (QA) Director/Senior Director to lead the company's clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with...

  • Director/Senior Director, Clinical Quality Assurance

    6 days ago

    South San Francisco, United States Annexon, Inc. Full time

    Work Location Corporate Headquarters (South San Francisco, CA) – Hybrid Position Summary Annexon Biosciences seeks a Quality Assurance (QA) Director/Senior Director to lead the company's clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with...

  • Associate Director, Clinical Quality Assurance

    5 days ago

    South San Francisco, United States Abdera Therapeutics Full time

    Job DescriptionJob DescriptionWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively...

  • Associate Director, Clinical Quality Assurance

    5 days ago

    South San Francisco, United States Remegen Biosciences, Inc. Full time

    Job DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...

  • Associate Director, Clinical Quality Assurance

    6 days ago

    South San Francisco, United States RemeGen Biosciences Full time

    ORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design...

  • Director, Quality Assurance

    5 days ago

    South San Francisco, United States Cellares Full time

    We are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and clinical manufacturing. This individual will be responsible to lead and grow the...

  • Director, Quality Assurance

    6 days ago

    South San Francisco, California, United States Cellares Full time

    We are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and clinical manufacturing.This individual will be responsible to lead and grow the...

  • Director, GMP Quality Assurance

    2 months ago

    South San Francisco, United States Alumis Inc. Full time

    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. We are seeking a Director of GMP Quality...

  • Director, GMP Quality Assurance

    1 month ago

    South San Francisco, United States Alumis Full time

    Job Description Job Description Salary: 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. We are...

  • Director, GMP Quality Assurance

    2 months ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: 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. We are...

  • Senior Director of GCP Clinical Quality Assurance

    2 weeks ago

    San Francisco, California, United States Nurix Therapeutics Full time

    Job DescriptionThe Senior Director of GCP Clinical Quality Assurance is responsible for partnering with Clinical Operations to ensure that quality and compliance are integrated into long term strategies and day to day operations.This role is instrumental in establishing, improving, and maintaining quality systems at Nurix and driving functional and...

  • AD or Director, GMP Quality Assurance contract

    1 day ago

    South San Francisco, United States GQR Full time

    Title: AD or Director, GMP Quality Assurance contractStatus: 6-month contractPart time, 25-30 hours per weekLocation: Hybrid South San Francisco 1 day a week onsite.Hourly rate: $120 per hour depending on experienceOverview: This is a hands-on position responsible for all assigned activities that ensure clinical trials adhere to applicable Good Manufacturing...

  • Manager, Quality Assurance

    2 months ago

    San Antonio, Texas, United States Worldwide Clinical Trials - USA Full time

    Who we are We're a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...

  • Quality Assurance Manager

    5 days ago

    San Francisco, United States Bayview Hunters Point Foundation for Community Improvement Full time

    Job Description Job Description Description: What We Do: Bayview Hunters Point Foundation has been at the heart of social justice for over 50 years, providing support services for predominantly low-income people of color in the Bayview and throughout San Francisco. Our mission is to build a community that is empowered, clean, safe, and healthy. We are...

  • Quality Assurance Assistant

    3 weeks ago

    South Bend, United States Allied Physicians Surgery Center LLC Full time

    Job DescriptionJob DescriptionCollaborates closely with and reports to the Director of Quality Management and Regulatory Compliance, Executive Director, Medical Director and Clinical Director. Assists Directors with developing and implementing Quality Improvement Plan and evaluates data and reports quarterly to Quality Improvement Committee. Attends meetings...