Remote Senior Executive QA Director, GCP

Erasca, Inc.

Northern, San Diego (KY, CA)

Hybrid

USD 250,000 - 290,000

Full time

7 days ago

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Benefits offered by this job

Paid Time Off

Holiday Leave

Medical, Dental and Vision Plans

Short- & Long-Term Disability

401(k) with company contribution

Job summary

Erasca, Inc., a clinical-stage precision oncology company, seeks a Senior or Executive Director of Quality Assurance GCP to lead GCP activities acrossPhases 1–3, regulatory submissions, and planned future commercial launches. Partner with clinical development and operations teams to implement GCP, GLP, GVP, and CDx strategies for a high‑functioning QA organization.

The role will provide strategic oversight, establish quality policies, manage inspections, and mentor QA staff while ensuring

Qualifications

Undergraduate degree in Biology, Chemistry, Physical Sciences, or related discipline preferred.
12+ years of experience including management of GCP quality in a pharmaceutical or biotech environment.
Experience with quality for registrational clinical trials and transition to commercial quality systems preferred.

Responsibilities

Provide strategic and tactical clinical quality oversight of all Erasca clinical programs.
Oversee quality for global Phase 3 trials and readiness for commercialization and launch.
Establish quality policies and procedures aligned with GCP, GVP, and GLP regulations and corporate policies.
Lead inspections and manage external GCP auditors; develop CAPA plans and ensure effectiveness checks.