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

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

Location : South San Francisco, CA (or Bay Area)

Company Type : Clinical-Stage Biotech

About Corvus Pharmaceuticals

Corvus Pharmaceuticals is a clinical-stage oncology company dedicated to the development of novel immunotherapies. Our mission is to discover and develop drugs that harness the immune system to conquer cancer. With a focus on pioneering the development of ITK inhibition, we are advancing a pipeline of investigational agents, including our lead candidate, soquelitinib, currently in a Phase 3 clinical trial for T-cell lymphoma. Our lean, innovative team is at a pivotal stage of growth, and every role has a direct impact on our mission.

Position Overview

We are seeking a highly skilled and motivated leader to own and manage our IT and Quality Systems. Reporting to senior leadership, this individual will be a foundational expert responsible for ensuring our systems remain 21 CFR Part 11 compliant and support our clinical and business operations. This is a high-impact, individual contributor role where you will have the opportunity to build a function and define our strategy for system management and data integrity.

Key Responsibilities

Computer System Validation (CSV) : Serve as the subject matter expert for all GXP computerized systems, including electronic data capture (EDC), trial master file (TMF), interactive response technology (IRT), and electronic quality management systems (eQMS). Manage the entire system lifecycle, utilizing a risk-based approach to prioritize activities and ensure compliance.

GXP Service Provider Management : Own the entire GXP service provider management process, including the selection, qualification, and ongoing oversight of vendors. Conduct GXP audits of service providers and collaborate to ensure compliance with all applicable regulations.

Data Integrity and Access Control : Develop, implement, and maintain policies and procedures to ensure the integrity, security, and traceability of all electronic records. Proactively manage user access and permissions across all systems, performing periodic reviews and ensuring compliance with audit trails.

Change Management & Systems Administration : Own the change control process for all GXP systems, applying a Quality by Design (QbD) mindset to ensure system changes are robust, well-documented, and do not introduce risk. Work closely with vendors and internal stakeholders to assess, approve, and implement system changes and upgrades in a controlled and compliant manner.

System Implementation and Evaluation : Lead the assessment, selection, and implementation of new GXP-compliant systems as the company grows. Collaborate with cross-functional teams to define business needs and ensure new systems are fit for purposes.

Audit Readiness : Prepare for and lead all system-related activities during internal audits and external regulatory inspections (e.g., FDA, EMA). Be prepared to present and defend our CSV and data integrity programs to regulatory authorities.

Policy & SOP Development : Draft, review, and maintain Standard Operating Procedures (SOPs), work instructions, and policies related to IT systems, data governance, and Part 11 compliance.

Required Skills & Qualifications

Bachelor’s degree in a scientific, engineering, or computer science field.

Minimum of 8+ years of relevant experience in a GXP environment within the pharmaceutical, biotech, or medical device industry.

Proven, hands-on experience with Computer System Validation (CSV) and a deep understanding of 21 CFR Part 11, GXP, and ICH guidelines.

Direct experience with GXP systems, including but not limited to electronic data capture (EDC), trial master file (TMF), interactive response technology (IRT), and electronic quality management systems (eQMS), as well as electronic signature platforms.

Demonstrated ability to manage projects, lead cross-functional teams, and work with external vendors.

Experience with a risk-based approach to quality and a Quality by Design (QbD) mindset is required.

Exceptional communication skills, both written and verbal, with the ability to clearly articulate complex technical and compliance concepts to a non-technical audience.

Experience in a small, fast paced, or startup environment is highly desirable. Prior QA experience is highly desirable.

Work Location : This is an on-site position based in our South San Francisco, CA office, with a requirement of 4 days per week on-site.

Salary Range : $150,000 - $200,000 per year.

Benefits : Corvus offers a competitive benefits package including health, vision, and dental insurance, accidental life insurance coverage, a stock options plan, and an annual bonus.

The level of the position (Associate Director or Director) will be determined based on the candidate's experience, skills, and qualifications.

For the Associate Director level : Proven track record of managing and validating GXP systems independently.

For the Director level : In addition to the above, a history of strategic leadership, mentorship, and building quality systems from the ground up, with a demonstrated ability to oversee a growing portfolio of systems and potential future team members.

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