Associate Director / Director, Quality Systems & Compliance

Location: South San Francisco, CA (On-site)
Reports to: VP of Quality Assurance

About Corvus Pharmaceuticals

Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering ITK inhibition to treat cancer and immune diseases. Our lead candidate, soquelitinib, is in a Phase 3 registration trial for T-cell lymphoma and a Phase 2 trial for Atopic Dermatitis (AD). We are a lean, fast-paced team dedicated to high-science drug development and improving patient lives.

The Role

We are seeking a hands-on, highly independent Director of Quality Systems. Your primary mission is the continuous improvement of our Quality Management System (QMS), closing execution gaps and refining procedures to ensure the highest standards of Patient Safety and Data Integrity.

This role ensures Corvus remains in a constant state of inspection readiness for the FDA and other global authorities. You will oversee vendor qualification and implement a robust Quality Risk Management (QRM) framework, while ensuring the organization meets GDPR requirements related to clinical quality data.

Key Responsibilities

1. QMS Continuous Improvement & Execution

  • Operational Excellence: Own the day-to-day lifecycle of the QMS (Deviations, CAPA, Change Control, Training); identify execution bottlenecks and implement direct, hands-on fixes.
  • Procedural Refinement: Author and update SOPs to ensure they are lean, practical, and compliant with Phase 3/BLA expectations across global jurisdictions.
  • KPIs & Metrics: Define and track Quality Key Performance Indicators (KPIs) to monitor system health and drive data-driven improvements.
  • Global Compliance: Ensure the QMS adheres to FDA, EMA, and Health Canada regulations, including the management of GDPR compliance within the quality framework.

2. Vendor & Supplier Qualification

  • Qualification Lifecycle: Manage the end-to-end quality oversight for all external GXP partners (CMOs, CROs, Labs), ensuring their performance supports registration-track data.
  • Quality Agreements: Independently draft and negotiate Technical Quality Agreements to define clear compliance accountability.
  • Audit Management: Plan and execute GXP audits of vendors; drive the remediation of all findings to maintain a compliant supply network.

3. Quality Risk Management & Inspection Readiness

  • Risk Framework: Operationalize ICH Q9 (QRM) to identify and mitigate risks across the organization, prioritizing patient safety and data reliability.
  • Inspection Lead: Serve as the primary point of contact and lead participant for health authority inspections and partner audits, ensuring a state of constant readiness.
  • Data Integrity: Implement and verify DI controls (ALCOA+) across all systems to safeguard clinical trial results.

Qualifications

  • Education: BS/MS, Ph.D. preferred, in natural sciences or biomedical sciences
  • Hands-on Experience: 10+ years in Biotech/Pharma QA, with a "doer" mindset and active participation in a Phase 3 study, NDA or BLA.
  • Regulatory Mastery: Deep expertise in 21 CFR Parts 11, 210, 211, ICH Q9/Q10, and global EudraLex (EMA) / Health Canada requirements.
  • GDPR Knowledge: Familiarity with GDPR requirements as they relate to clinical quality and vendor data management.
  • Operational Independence: Proven ability to work autonomously on-site in South San Francisco, taking full ownership of projects from identification to completion.
  • Technical Writing: Superior ability to write SOPs and Quality Agreements that are clear, practical, and regulatory-compliant.

Level will be determined based on the experience.

Salary range: $150,000 – $210,000.

If you are interested, please submit a cover letter and your resume to careers@corvuspharma.com