Job Details

Overview

Position: Associate Director/Director IT & QA Systems (Level commensurate with experience)

Company: Corvus Pharmaceuticals is a clinical-stage biotechnology company focused on immunotherapies to treat cancer. Our team develops and advances IT and QA systems to support research and clinical operations.

Base pay range

$150,000.00/yr - $200,000.00/yr

Location and work arrangement

Work Location: On-site at our South San Francisco, CA office, with 4 days per week on-site required.

Job Description

Associate Director/Director, IT & Quality Systems (Level Commensurate with Experience)

Key Responsibilities

• Own and manage IT and Quality Systems; ensure 21 CFR Part 11 compliance; support clinical and business operations.
• Computer System Validation (CSV): serve as SME for GXP computerized systems (EDC, TMF, IRT, eQMS) and manage system lifecycle with a risk-based approach.
• GXP Service Provider Management: oversee selection, qualification, and audits of vendors to ensure regulatory compliance.
• Data Integrity and Access Control: develop and maintain policies to ensure data integrity, security, traceability, and audit trails; manage user access.
• Change Management & Systems Administration: own change control for GXP systems with QbD mindset; collaborate with vendors and stakeholders to implement changes.
• System Implementation and Evaluation: lead assessment, selection, and rollout of new GXP systems; ensure fit-for-purpose solutions.
• Audit Readiness: prepare for internal audits and regulatory inspections; present CSV and data integrity programs to authorities as needed.
• Policy & SOP Development: draft and maintain SOPs, work instructions, and policies for IT systems, data governance, and Part 11 compliance.

Required Skills & Qualifications

• Bachelor's degree in a scientific, engineering, or computer science field.
• Minimum 8+ years of relevant experience in a GXP environment within pharma/biotech/medical device.
• Proven hands-on experience with CSV and understanding of 21 CFR Part 11, GXP, and ICH guidelines.
• Direct experience with GXP systems (EDC, TMF, IRT, eQMS) and electronic signatures.
• Project management experience; ability to lead cross-functional teams and work with vendors.
• Risk-based quality approach and a Quality by Design (QbD) mindset.
• Strong communication skills to convey technical and compliance concepts to non-technical audiences.
• Experience in a small, fast-paced or startup environment; QA experience is desirable.

Preferred/Desirable

• Prior QA experience; leadership and strategic system-building experience for Director level.

Compensation & Benefits

• Salary: $150,000 - $200,000 per year.
• Benefits include health, vision, and dental insurance, accidental death and dismemberment coverage, stock options, and an annual bonus.

Employment type

• Full-time

Seniority level

• Associate Director or Director

Industries

• Biotechnology Research
• Pharmaceutical Manufacturing