Sr/Exec Director, Quality Assurance GCP

Erasca•San Diego, CA

3d•$250,000 - $290,000

About The Position

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. Position Summary: Reporting to the Chief Operating Officer, the Senior or Executive Director Quality Assurance GCP will lead GCP activities and have responsibility for strategic and tactical oversight and implementation of QA GCP operations in support of Erasca’s clinical development programs (Phase 1, 2, 3), regulatory submissions, and planned future commercial launches. As a key member of the Quality Assurance leadership team, this person will partner with relevant clinical development and operations teams to execute GCP, GLP, GVP, and CDx strategies and participate in the further development of a high functioning Quality organization.

Requirements

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 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, and CDx 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

Nice To Haves

transition from clinical stage to commercial quality systems highly preferred
application of phase-appropriate quality systems across the product development lifecycle and on to commercial launch highly preferred
experience interacting with global regulatory agencies through the drug product approval process preferred
oversight of GVP, GLP, and CDx activities preferred

Responsibilities

Ensure strategic and tactical clinical quality oversight of all Erasca 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, and GLP 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
Develop a risk-based GCP audit program and compliance strategy for Erasca clinical study programs
Prepare and lead GCP and GVP inspection; eventually hire, develop, and mentor QA Audit and Clinical Inspections staff
Manage external GCP auditors, support timely review 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 sites and training staff on regulatory inspection management best practices
Represent Clinical Quality during global regulatory inspections at Erasca including supporting regulatory inspections at global clinical sites for Erasca clinical studies
Work with Clinical Operations to oversee study documentation, including TMF, for accuracy and inspection 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 with function heads, ensure GCP, GVP, GLP, and CDx vendors comply with applicable quality programs and regulations or guidelines and are prepared for Regulatory inspections
Align with GMP Quality Assurance and Quality Systems 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 quality metrics and assess the state of GCP, GVP, GLP, and CDx Quality 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 quality management
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