Director, Clinical Quality Assurance - Contractor
Alumis
5 months ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Clinical Quality Assurance Director (CONTRACTOR) — Essential Duties & Responsibilities
- Establish and maintain 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 subject matter expert and point of contact for ICH-GCP/GVP matters for assigned studies.
- Establish/maintain study-specific audit plans; perform audits and lead external quality auditors as needed.
- Represent Quality on project teams, Health Authority inspections, and operational meetings with service providers/CROs.
- Provide oversight and review of key Clinical and IND/NDA-enabling documents.
- Review clinical trial documentation for data integrity and compliance with Good Clinical Practice; conduct root cause analysis for recurring issues.
- Support inspection readiness; act as primary liaison with Health Authority and internal/external partners.
- Support selection/qualification of clinical service providers and develop periodic compliance/metric reports.
Qualifications / Education & Experience
- 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, including solid oral dosage forms.
Knowledge / Skills / Abilities
- Extensive knowledge of FDA regulations/practices and ICH guidance; strong global health authority knowledge.
- Hands-on experience in drug life cycle management.
- Proven track record working with service providers and CROs.
- Ability to make timely, sound quality decisions in complex clinical/compliance/regulatory situations; comfortable with ambiguity.
- Knowledge of Quality Management Systems; experience implementing/managing QMS in pharma.
- Excellent written and verbal communication; collaborative/analytical/interpretive skills.
- Ability to work with minimal supervision; prioritize to timelines; motivate/influence others (prior management experience required).
- Cross-functional leadership experience.
- ~15% travel required.
Compensation / Location
- Salary range: $193,000–$242,000 USD annually (estimate).
- South San Francisco, CA; onsite Tuesday–Thursday.
- Establish and maintain 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 subject matter expert and point of contact for ICH-GCP/GVP matters for assigned studies.
- Establish/maintain study-specific audit plans; perform audits and lead external quality auditors as needed.
- Represent Quality on project teams, Health Authority inspections, and operational meetings with service providers/CROs.
- Provide oversight and review of key Clinical and IND/NDA-enabling documents.
- Review clinical trial documentation for data integrity and compliance with Good Clinical Practice; conduct root cause analysis for recurring issues.
- Support inspection readiness; act as primary liaison with Health Authority and internal/external partners.
- Support selection/qualification of clinical service providers and develop periodic compliance/metric reports.
Qualifications / Education & Experience
- 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, including solid oral dosage forms.
Knowledge / Skills / Abilities
- Extensive knowledge of FDA regulations/practices and ICH guidance; strong global health authority knowledge.
- Hands-on experience in drug life cycle management.
- Proven track record working with service providers and CROs.
- Ability to make timely, sound quality decisions in complex clinical/compliance/regulatory situations; comfortable with ambiguity.
- Knowledge of Quality Management Systems; experience implementing/managing QMS in pharma.
- Excellent written and verbal communication; collaborative/analytical/interpretive skills.
- Ability to work with minimal supervision; prioritize to timelines; motivate/influence others (prior management experience required).
- Cross-functional leadership experience.
- ~15% travel required.
Compensation / Location
- Salary range: $193,000–$242,000 USD annually (estimate).
- South San Francisco, CA; onsite Tuesday–Thursday.