Sr/Exec 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 cancer’s 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 developmentand operationsteamsto 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, andCDxvendors comply 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 to establishquality 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 for qualitymanagement 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 and in a timely manner including 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+ years of experience including management of GCP Quality in a pharmaceutical or biotech environment in progressively responsible Quality roles required Experience with quality for registrational clinical trials required; transition from clinical stage to commercial quality systems highly preferred Experience with the application of phase-appropriate quality systems across the product development lifecycle and on to commercial launch highly preferred Experience in regulatory inspections required, experience interacting with global regulatory agencies through the drug product approval process preferred Extensive experience participating in regulatory agency inspections of global clinical research activities Deep expertise in GCP Quality required, oversight of GVP, GLP, andCDx activities 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, with demonstrated application of GCP and GLP principles in clinical research Must have excellent written and verbal communication skills with the ability to tailor communication to all levels and prepare and present appropriate updates to functional groups and leaders Demonstrated ability to achieve high performance goals 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, 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 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 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. #J-18808-Ljbffr Erasca