GxP and Regulatory QA Lead

Soley Therapeutics is a biotechnology company that was created with the belief that drug discovery and development should be faster and less expensive, with a much higher probability of success. To achieve this goal, we are pioneering a novel, fully integrated approach that combines data and machine learning insights at every step of the process. We are a multi-disciplinary team that brings together experts in drug development, data engineering, and machine learning to create a cohesive platform. Our end goal is to create life-changing medical treatments by combining expertise in technology and life sciences with a comprehensive view of the entire drug discovery and development process. Soley Therapeutics is committed to hiring a world-class team that brings together a wide variety of different skills and experiences. We are committed to inclusion across race, gender, age, religion, identity, and experience, and believe that diversity makes us stronger by bringing in new ideas and perspectives. We strive to create a workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. About the Role Soley is hiring a self-motivated, experienced and detail-oriented GxP and Regulatory QA Lead to join our fast-growing drug discovery company. The GxP and Regulatory QA Lead will be responsible for overseeing and ensuring quality and compliance of company's clinical/non-clinical operations related to drug discovery processes. What You’ll Do Develop, implement, administer, maintain and continuously improve a new and effective Quality Management System (QMS) for Soley using Veeva platform. Create and manage Veeva workflows, lifecycle states, tasks and controlled document routing. Administer system and provide end-user support and troubleshoot any Veeva-related issue as needed. Manage controlled documents, quality workflows, training assignments, GxP (GLP/GCP/GMP) compliance and FDA 21 CFR Part 11 compliance for clinical/non-clinical operations. Manage the lifecycles of GxP documents (i.e. creation, review, approval, effective date assignment, version control and archival). Support QMS processes including deviations, CAPA, change controls and audit management. Collaborate with cross-functional teams (R&D, Clinical, Non-clinical, Operations, Engineering, CRO, CDMO, CMC, etc.) to ensure timely resolution of quality events. Perform quality checks for accuracy, consistency and data integrity. Administer training assignments, curricula and compliance tracking via Veeva Training. Maintain accurate training records and generate compliance reports. Maintain documentation readiness of audits and inspections. Support internal/external audits. Manage corrective/preventive actions from audit findings. Ensure adherence to ALCOA+ principles throughout drug development lifecycle. Support periodic reviews of QMS records for completeness and data integrity. Manage Computer System Validation (CSV) including requirements, testing and change control. Stay up-to-date with relevant regulations and guidelines from regulatory bodies like Food and Drug Administration (FDA) and European Medicines Agency (EMA). Ensure that company's processes, documentation and systems comply with these regulations and other standards like International Organization for Standardization (ISO). Develop and monitor Key Performance Indicators (KPI’s) to track quality metrics. Identify opportunities for Continuous Improvements and Process/Efficiency Optimization. Perform other related duties as assigned. What You Bring 7+ years of experience in Quality Assurance/Quality Control roles in drug discovery within life science, pharmaceutical or biotechnology industry. 5+ years of experience implementing, administering and maintaining various Veeva Vault modules (QualityDocs, Training, QMS, RIM, eTMF, CTMS, Safety, etc.). In-depth understanding of International Organization for Standardization (ISO) requirements and regulatory requirements for Food and Drug Administration (FDA) and European Medicines Agency (EMA). Working knowledge of GxP and FDA regulations (e.g. GLP, GCP, GMP, 21 CFR Part 11, etc.). Good knowledge of E/M/Q/S-series ICH guidelines required at discovery, Investigational New Drug (IND) and New Drug Application (NDA) stages. Experienced with FDA/EMA submission processes for IND and NDA. Experienced with managing Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) workflows. Good understanding about PK/PD Modeling & Simulation and different stages of clinical trials. Good understanding about ALCOA+ principles for data integrity. Experienced working with external partners (e.g. CRO, CDMO, CMC, etc.). Extensive experience in leading internal and external audits and inspections. Knowledgeable about automation for drug discovery processes a plus. Strong analytical skills with the ability to analyze data, draw conclusions and make recommendations for improvements. Excellent written and verbal communication skills. Ability to work independently and as part of a team. Strong attention to detail and documentation accuracy. Good computer skills including proficiency with Microsoft Office. Bachelor’s or advanced degree in Science (Chemistry, Biology, Pharmacy), Engineering or related fields. Seniority Level Mid-Senior level Employment Type Full-time Job Function Research Referrals increase your chances of interviewing at Soley Therapeutics by 2x #J-18808-Ljbffr