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 Senior Associate of Quality Systems, reporting to the Senior Manager of Quality Systems. The role will interact with individuals across the company to ensure compliance with Documentation and Training requirements at Alumis. The Senior Associate will be responsible for supporting the implementation of Alumis Quality Management System and maintaining compliance with established Document Control, Records Management, and Training aspects of the Alumis QMS. The successful candidate will promote the culture of ethics, integrity, and proactive quality management at Alumis. This position requires knowledge of Quality Systems and relevant regulations.
Essential Duties Responsibilities
- Act as a System Administrator for the Veeva Quality Docs and Veeva Training Vaults.
- Support implementation of new Veeva Vaults as needed.
- Perform onboarding/offboarding activities as needed for all employees/consultants/contractors.
- Assign training learner roles to individuals based on their job description and deploy training requirements in Veeva.
- Support implementation of quality systems changes and process improvement.
- Promote compliance and continuous improvement by training and supporting all users on Veeva processes.
- Maintain repository of Veeva user's feedback and inquiry.
- Produce quality metrics reports for training compliance as needed.
- Maintain controlled documents archival process (both in paper and electronic QMS system).
- Maintain Alumis Glossary and list of functional roles.
- Create Work Instructions for e-DMS and Training activities as needed.
- Ensure compliance of Veeva processes with Alumis internal procedures.
- Support Sr Manager of Quality Systems as needed.
- Support other Quality Assurance activities as needed.
- Support regulatory authority inspections and internal audits as needed.
Education & Experience
- Bachelor's or advanced degree in Biology, Chemistry, or technical related field.
- Minimum 3 years of Quality Systems experience in biotechnology or pharmaceutical.
- Experience in implementing and managing electronic Quality Management Systems. Experience working with Veeva Vault is preferred.
Knowledge Skills Abilties
- Previous knowledge of Quality Management Systems; experience in maintaining quality systems in the pharmaceutical industry.
- Previous experience administrating electronic Document Management Systems and electronic Training Management Systems.
- Working knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
- Excellent verbal and written communication skills.
- Collaborative, analytical & interpretative skills.
- Ability to work according to set priorities and consistently meet timelines.
- Ability to communicate with individuals cross-functionally.
- Collaborative, analytical, and interpretative skills.
Alumis Values
- Elevate
- Challenge
- Nurture
This position is located in South San Francisco, CA. At this time, we are not considering remote applicants.
This is a nonexempt position with a salary range of $98,000 USD to $130,000 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.