Director Or Sr Director Qa Gcp

Erasca is 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.

• Ensure strategic and tactical clinical quality oversight of Erasca clinical programs

• Establish quality policies and procedures to ensure systems align with applicable GCP, GLP, and device 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 Study Documents and provide QA guidance on quality compliance issues, regulatory risk, and process improvements

• In collaboration with line function heads, ensure GCP, GLP, and device vendors comply with the applicable quality program and regulations or guidelines and are prepared for Regulatory inspections

• Align with internal quality functions on the development and optimization of the quality infrastructure, systems, and policies to ensure continuity within quality operations.

• Collaborate with Development, Research, and Quality Assurance colleagues to establish metrics and report on the state of GCP, GLP, and CDx Quality and compliance of Erasca clinical studies

• 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.

• Prepare and lead GCP and GVP inspections, partner with QA Audit and Clinical Inspections staff

• Develop metrics to support GCP activities and quality management review

• Lead, manage, develop, and mentor direct report(s)

• Perform all duties in keeping with the Company's core values, policies, and all applicable regulations

• Undergraduate degree in in Biology, Chemistry, Physical Sciences, or related discipline

• 10-12+ years of experience including management of GCP Quality in a pharmaceutical or biotech environment in progressively responsible Quality roles required

• Oversight of GLP and CDx activities preferred

• Extensive knowledge of ICH GCP, other relevant ICH guidelines (E8, E2F, E3), and US, European, and ROW regulatory requirements (minimally US FDA) regarding applicable drug development regulations.

• Experience with transition from Phase 1-3 to commercial quality systems is a plus.

• Previous experience working with FDA and participating in regulatory agency inspections of clinical research activities

• Excellent interpersonal and influencing skills

• Must have good 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

• Strong learning orientation, curiosity, and commitment to science and patients

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.