Quality Assurance

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.