Sr/Exec Director, Quality Assurance GCP

Erasca, Inc.; Northern, San Diego (KY, CA); Hybrid; USD 250,000 - 290,000; Full time

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.

Skills

Quality leadership

GCP expertise

Regulatory experience

Communication

Program management

Education

Bachelor's degree in Biology or related

Job description

San Diego, CA, South San Francisco, CA, or remote

Erascais a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancers most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer.

PositionSummary:

Reporting to theChief Operating Officer, theSenior or ExecutiveDirector QualityAssuranceGCPwill lead GCPactivities and have responsibility for strategic and tactical oversightand implementationof QAGCPoperations in support ofErasca'sclinical development programs (Phase1,2, 3), regulatory submissions,and planned future commercial launches.As a key member of the Quality Assurance leadership team, this person will partner withrelevant clinical developmentandoperationsteamsto executeGCP, GLP, GVP, andCDxstrategies andparticipatein the further development of a high functioning Qualityorganization.

Essential Duties and Responsibilities:

• Ensurestrategic and tacticalclinical quality oversight ofallErasca clinical programs
• Provide seamless Quality oversight of global Ph3 trials and assure readiness for commercialization and launch
• Establish quality policies and procedures to ensure systems align with applicable GCP, GVP,andGLP global health authority regulations, guidance, and corporate policies
• Provide quality and compliance input and guidance to partners and stakeholders to achieve continuous quality improvement and effective quality controls
• Represent clinical QA on project and study teams, perform technical review of Clinical StudyDocumentsandprovideQA guidance on quality compliance issues, regulatory risk, and process improvements
• Develop a risk-based GCP audit program and compliance strategy for Erasca clinical study programs
• Prepare and lead GCP and GVP inspection; eventuallyhire, develop, and mentor QA Audit and Clinical Inspections staff
• Manage external GCP auditors,supporttimelyreview of audit reports,and communicate findings to auditees, cross-functional representatives, and management. Ensure corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate
• Support global regulatory, due diligence, and partner inspections including preparing sitesand training staff on regulatory inspection management best practices
• Represent Clinical Quality during global regulatory inspections at Erasca including supporting regulatory inspections atglobalclinical sites for Erasca clinical studies
• Work with Clinical Operations to oversee study documentation,including TMF,for accuracy andinspection readiness
• Perform quality reviews of Clinical Study Documents with a focus on compliance,regulatory requirements,and risk assessment. The study documents include but are not limited to: Study Protocols, ICFs, Annual Reports (e.g., DSUR), other subject-facing documents (brochures, recruitment materials), Investigator's Brochure, and CSR
• In collaboration withfunction heads, ensure GCP, GVP,GLP,andCDxvendorscomply withapplicable quality programsand regulationsorguidelines and are prepared for Regulatory inspections
• Align withGMP Quality Assurance and Quality Systemson the developmentandoptimization ofthequality infrastructure, systems, and policiesto ensurecontinuity within quality operations
• Collaborate with Development, Research, and Quality Assurance colleagues toestablishquality metrics and assess the state of GCP, GVP, GLP, andCDxQuality compliance across Erasca clinical studies.
• Compile, track, and analyze GCP quality KPIs and vendor performance for all Erasca-initiated clinical studies, and prepare quarterly reports forqualitymanagement
• Conduct gap analysis and risk assessment for critical study level activities that may impact subject safety and/or the quality and reliability of data, including but not limited to: Study Design and Protocol Requirements, Clinical Vendors and Service Providers-Transferred Obligations, contractual duties per SOW, and overall performance, Internal processes (e.g., vendor oversight), and Clinical Site and PI assessment and performance.
• Escalate quality events, IPDs, potential serious breaches to relevant leadership as needed andin a timely mannerincluding initiating CAPAs and CIs to address major findings and gaps.
• Lead, manage, develop,and mentor direct reports
• Perform all duties in keeping with the Company’s core values, policies,and all applicable regulations

Required Education and Experience:

• Undergraduate degree in Biology, Chemistry, Physical Sciences, or related disciplinepreferred
• 12+ yearsofexperienceincludingmanagement ofGCPQuality in a pharmaceutical or biotech environment in progressively responsible Quality rolesrequired
• Experience with quality for registrationalclinicaltrialsrequired; transition from clinical stage tocommercial quality systems highly preferred
• Experience with the application of phase-appropriate quality systems across the product development lifecycleand on to commercial launchhighly preferred
• Experience in regulatory inspectionsrequired, experience interacting with globalregulatory agencies through the drug product approval processpreferred
• Extensiveexperienceparticipatingin regulatory agency inspections ofglobalclinical research activities
• Deepexpertisein GCP Qualityrequired, oversight ofGVP,GLP,andCDxactivities preferred
• Extensive knowledge of ICH GCP (E6) and other relevant ICH guidelines (including E8, E2F, and E3), as well as FDA, EMA, Health Canada (HC), PMDA, and other global regulatory requirements governing drug development, withdemonstratedapplication of GCP and GLP principles in clinical research
• Must haveexcellentwritten and verbal communication skillswith theability to tailor communication to all levels and prepareand presentappropriate updatesto functional groupsand leaders
• Demonstrated ability to achievehigh performancegoals and meet deadlines in a fast-paced environment
• Excellent interpersonal and influencing skills
• Strong learning orientation, curiosity, and commitment to science and patients

The anticipated salary range for this position is $250,000 - 290,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc etera. In addition to base salary, the h ired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.

Along with our casual, collaborative , and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off , Holiday , and Sick Leave , Medical, Dental and Vision Plans , Short- and Long-Term Disability , Basic and Voluntary Life/AD&D Coverage , Flexible Spending Account s (FSA , HSA, and Commute ) , Critical Illness and Accident Coverage , Pet Insurance, Employee Assistance Program , 401(k) Plan with Erasca contribution , and the opportunity to participate in an E mployee S tock P urchase P rogram.

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race , religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.