Position:

Quality Assurance Location:

Alameda, CA (Onsite)

Duration:

12+ Months (with possible extension) Job description: As a Quality Assurance, you would be involve in overseeing GxP compliance, managing health authority inspections, and aligning quality systems for oncology drug development. Key Responsibilities Computer Software Assurance/Validation (CSV/CSA): Author, review, and execute validation deliverables including User Requirements Specifications (URS), Functional Specifications (FS), Configuration Specifications (DS), and

IQ/OQ/PQ

test scripts.

Quality Systems Design:

Assess current states, identify gaps, and implement improvements across Clinical and commercial QA standards.

Compliance & Metrics:

Track and trend metric data, review deviations, and manage Corrective and Preventive Actions (CAPAs).

Process Optimization:

Translate complex quality processes (CAPA, Deviations, Change Control, Audits) into functional system requirements and risk-based testing strategies.

Inspection Readiness:

Prepare for and support health authority inspections (such as from the FDA), mock audits, and vendor evaluations.

Client Advisory:

Act as a trusted advisor to quality leaders during workshops, proof-of-concepts, and end-to-end system rollouts.

Cross-Functional Partnership:

Collaborate with Clinical Operations, Regulatory Affairs, and Translational Medicine to provide compliance guidance.

Core Requirements Experience:

Generally requires 5-8+ years of related experience in GxP quality assurance or compliance within the biotech/pharmaceutical industry.

Regulatory Knowledge:

Deep familiarity with GxP regulations.

Technical Skills:

Experience in validating Veeva Vault system

Skills:

Strong problem-solving, document authorship, and stakeholder-influencing capabilities.