SrExec Director, Quality Assurance GCP

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 cancersmost 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 ofErascasclinical development programs (Phase12 3) regulatory submissionsand planned future commercial 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 GVPandGLP 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 auditorssupporttimelyreview of audit reportsand 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 documentationincluding TMFfor accuracy andinspection readiness
• Perform quality reviews of Clinical Study Documents with a focus on complianceregulatory requirementsand 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) Investigators Brochure and CSR
• In collaboration withfunction heads ensure GCP GVPGLPandCDxvendorscomply 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 developand mentor direct reports
• Perform all duties in keeping with the Companys core values policiesand 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 ofGVPGLPandCDxactivities 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 $250000 - $290000. 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 etcetera. In addition to base salary the hired 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 Accounts (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 Employee Stock Purchase Program.

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.