Director, Clinical Quality Assurance - Contractor
Alumis
August 06, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Responsibilities:
- Establish and maintain the ICH-GCP Clinical QA programs, policies, and procedures.
- Ensure ongoing clinical programs comply with applicable health authority regulations, guidelines, and internal SOPs.
- Serve as primary ICH-GCP Clinical QA SME and point of contact for ICH-GCP/GVP matters for assigned studies/initiatives.
- Establish/maintain study-specific audit plans; perform audits and lead external quality auditors as needed.
- Represent Quality on project teams, Health Authority Inspections, service provider/CRO operational meetings, and Clinical QA meetings.
- Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
- Review clinical trial documentation for data integrity and compliance; perform root cause analysis for recurring issues.
- Support inspection readiness; act as primary liaison with Health Authority and internal/external partners.
- Support clinical service provider selection/qualification and develop periodic compliance/metric reports.
Qualifications:
- Bachelor’s or advanced degree in Biology, Chemistry, or related field.
- Minimum 10 years of ICH-GCP/GVP Quality Assurance experience.
- Auditing experience (e.g., investigator sites, clinical trial vendors/processes).
- Strong understanding of small molecule products with direct experience in solid oral dosage forms.
Skills/Abilities:
- Extensive knowledge of FDA regulations/practices and ICH guidance; strong global health authority knowledge.
- Hands-on drug life cycle management experience.
- Proven track record working with service providers and CROs.
- Ability to make timely, sound quality decisions amid complex clinical/compliance/technical/regulatory considerations.
- Knowledge of Quality Management Systems; ability to implement/manage quality systems.
- Excellent verbal and written communication; collaborative/analytical/interpretive skills.
- Ability to work with minimal supervision; prioritize to meet timelines; motivate/influence others (prior management experience required).
- Ability to lead cross-functional activities.
- ~15% travel required.
Benefits (if applicable):
- 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 snacks and drinks.
- Establish and maintain the ICH-GCP Clinical QA programs, policies, and procedures.
- Ensure ongoing clinical programs comply with applicable health authority regulations, guidelines, and internal SOPs.
- Serve as primary ICH-GCP Clinical QA SME and point of contact for ICH-GCP/GVP matters for assigned studies/initiatives.
- Establish/maintain study-specific audit plans; perform audits and lead external quality auditors as needed.
- Represent Quality on project teams, Health Authority Inspections, service provider/CRO operational meetings, and Clinical QA meetings.
- Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
- Review clinical trial documentation for data integrity and compliance; perform root cause analysis for recurring issues.
- Support inspection readiness; act as primary liaison with Health Authority and internal/external partners.
- Support clinical service provider selection/qualification and develop periodic compliance/metric reports.
Qualifications:
- Bachelor’s or advanced degree in Biology, Chemistry, or related field.
- Minimum 10 years of ICH-GCP/GVP Quality Assurance experience.
- Auditing experience (e.g., investigator sites, clinical trial vendors/processes).
- Strong understanding of small molecule products with direct experience in solid oral dosage forms.
Skills/Abilities:
- Extensive knowledge of FDA regulations/practices and ICH guidance; strong global health authority knowledge.
- Hands-on drug life cycle management experience.
- Proven track record working with service providers and CROs.
- Ability to make timely, sound quality decisions amid complex clinical/compliance/technical/regulatory considerations.
- Knowledge of Quality Management Systems; ability to implement/manage quality systems.
- Excellent verbal and written communication; collaborative/analytical/interpretive skills.
- Ability to work with minimal supervision; prioritize to meet timelines; motivate/influence others (prior management experience required).
- Ability to lead cross-functional activities.
- ~15% travel required.
Benefits (if applicable):
- 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 snacks and drinks.