Role Description The Senior Director of Quality Excellence (Systems & Technology) is a strategic quality leader responsible for shaping, executing, and continuously advancing the enterprise Quality Management System (QMS) and Quality systems operating model across Praxis Precision Medicines. This individual provides vision and direction for all Quality Systems functions including: - Veeva QMS governance - Document control - GxP training administration - Validation and inspection readiness - Supplier oversight for Quality Systems and GxP computerized system providers This role ensures a compliant, efficient, and scalable quality infrastructure that supports the company’s global clinical, manufacturing, and commercial operations. The Senior Director serves as the organization’s subject matter expert on GxP system compliance, regulatory readiness, and quality systems excellence. This role is accountable for: - Strategy, oversight, and continuous improvement of Praxis’s QMS and validation programs - Ensuring all GxP systems are fit for intended use and maintained in a controlled state - Aligning with current industry expectations (e.g., CSA concepts and GAMP 5) Partnering closely with senior leadership across Quality, Clinical, Technical Operations, and IT, the Senior Director drives a culture of proactive quality, operational discipline, and continuous improvement. Primary Responsibilities - Lead the strategy, governance, and continuous improvement of Praxis’s enterprise QMS to ensure compliance with global GxP regulations. - Serve as the process owner for QMS elements including document control, deviation/CAPA management, change control, training, and risk management. - Provide leadership and oversight for computerized lifecycle controls (CSV/CSA) for GxP computerized systems. - Partner with IT, Clinical Operations, Technical Operations, and Commercial teams to establish risk-based lifecycle standards. - Evaluate and qualify vendors, CROs, and CMOs supporting Praxis systems. - Maintain oversight of electronic systems, including Veeva QMS. - Lead the global GxP training administration program. - Establish and oversee QMS governance mechanisms. - Ensure ongoing inspection readiness across all GxP functions. - Monitor evolving regulatory expectations and implement timely updates. - Define, monitor, and report key QMS and validation metrics. - Lead, mentor, and develop a high-performing team of QMS and validation professionals. - Represent Quality leadership in enterprise governance and initiatives. - Drive sustained inspection readiness and execution support. Qualifications - BS/BA in a relevant scientific discipline, or ASQ or equivalent professional certification; equivalent experience considered. - Minimum 15 years of progressive experience in the pharmaceutical or biotechnology industry, with direct Quality Systems and Quality Assurance experience; at least five years in a leadership role. - Demonstrated expertise in developing, implementing, and managing enterprise QMS across clinical, manufacturing, and commercial functions. - Proven success governing QMS processes such as document control, training, deviation/CAPA, change management, and risk management. - Hands-on experience validating GxP and enterprise systems. - Demonstrated leadership experience supporting both clinical-stage and commercial operations environments. - Documented history supporting regulatory inspections and partner audits. - Strong working knowledge of FDA, EMA, and global GxP regulations. - Demonstrated ability to analyze and optimize quality processes. - Strategic, solutions-driven quality leader with excellent collaboration, communication, and influencing skills. - Proficient in Veeva Vault applications, DocuSign, and SharePoint. Requirements - The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. - Comfort with screen work, basic hand coordination, and focus. - Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Benefits - 99% of the premium paid for medical, dental, and vision plans. - Company-paid life insurance, AD&D, disability benefits, and voluntary plans. - 401(k) contributions matched dollar-for-dollar up to 6%. - Long-term stock incentives and ESPP. - Discretionary quarterly bonus. - Flexible wellness benefit. - Generous PTO, paid holidays, and company-wide shutdowns. Company Description Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Our core values of Trust, Ownership, Curiosity, and Results are foundational to every aspect of our business. At Praxis, we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion.

• Leads and manages signal management activities (clinical surveillance, signal identification, validation, analysis and prioritization) and closely collaborates with medical monitors and clinical scientists to provide clinical assessment and recommendations for continuous benefit-risk evaluation throughout the lifecycle of Definium medicinal products, and in compliance with regulatory requirements and company standard operating procedures • Responsible for providing high-level safety expertise in clinical evaluation of all AEs including review of all safety case narratives, aggregate safety data, and relevant literature within or external to the safety database to assess the impact on the benefit-risk profile throughout the lifecycle of Definium products • Leads and collaborates cross-functionally with medical and clinical scientists to develop, implement and maintain risk management activities which may include benefit-risk analysis in sections of clinical trial protocols, Investigators Brochure, informed consents, Clinical Study Reports, periodic reports (DSURs, PBRERs, PADERs), and/or any applicable risk management plans and REMS obligations • Represents PV in collaborating with relevant company stakeholders in the development, review, and/or maintenance of Definium products Reference Safety Information, company core safety information, and other labeling, as required or directed • Prepares and reviews key safety sections of the Investigators Brochure, protocols, informed consents, clinical study reports, and regulatory filings, as required • Provides strategic input into regulatory responses and/or requests and clinical development programs • Serves as a member of the safety governance committee providing safety analysis reports and/or presentations to characterize and communicate changes or key insights into Definium product(s) • Responsible for keeping current with global Pharmacovigilance regulations and industry standards especially as it pertains to risk management and signal management practices • Works collaboratively with internal and external Pharmacovigilance stakeholders and team members to ensure regulatory compliance and maintain Pharmacovigilance quality system • Acts as the Subject Matter Expert in risk management and signal management procedures and processes during audits and inspections

• Own and lead the global strategy for Expanded Access Programs and Late Stage development, aligned with asset lifecycle objectives, patient access goals, and regulatory expectations • Partner with the CMO, Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead and Program Leadership to ensure EAP and Late Stage clinical activities are fully integrated into the overall asset strategy and Target Product Profile (TPP) • Serve as the clinical development lead for governance discussions related to post‑approval and access strategies, clearly articulating risks, trade‑offs, and recommendations • Design and implement Expanded Access Programs, including protocol development, eligibility criteria, safety oversight, and operational execution • Lead cross‑functional planning to ensure EAPs are compliant, scalable, ethically sound, and aligned with regulatory guidance • Provide clinical leadership for benefit–risk assessment, safety monitoring, and ongoing program evaluation • Define potential phase 4 objectives and lead the design, plan and execution of potential phase 4 studies, ensure potential phase 4 program objectives, including real‑world evidence generation, long‑term safety, effectiveness, and differentiation in the treatment landscape • Lead the design, planning, and execution of late stage and prepare for the possibility of Phase 4 studies, including protocol development, data collection strategies, and interpretation of outcomes • Ensure late stage and any potential Phase 4 program design address regulatory commitments, payer needs, and scientific gaps • Lead preparation and review of clinical content for regulatory submissions and interactions as applicable • Act as a clinical subject matter expert in interactions with U.S. and ex‑U.S. health authorities related to Expanded Access and Late Stage activities • Oversee clinical input into Investigator Brochures, clinical study reports, in collaboration with Regulatory Affairs • Work collaboratively with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Project Management to ensure high‑quality execution • Establish and maintain relationships with key investigators, advisors, and external experts to support EAP and late stage/potentially Phase 4 objectives • Provide clinical leadership within matrix teams, modeling accountability, collaboration, and scientific rigor

• Serves as a responsible member of the clinical and/or as the clinical representative to a global development team • Works cooperatively with project team members to provide clinical development expertise and leadership • Providing therapy area medical and scientific expertise in evaluation and presentation of data and trial results • Writing and editing of clinical study protocols, clinical study reports, manuscripts, and other study-related documents • In partnership with Regulatory Affairs and Project Management, oversee and ensure the quality, coordination and timeliness of clinical sections of IND's, Investigator Brochures, CTA's, ISS', ISE's and clinical expert reports, including writing and editing • Monitors patient data and study-related information related to clinical study sites and clinical trial participation, including data science approaches • Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection, blinded data monitoring • Liaises with statisticians and programmers to help develop and implement the statistical data analysis plans • Work with Medical Writing to prepare abstracts, manuscripts and presentations for external meetings • Create an atmosphere of innovation and continual improvement • Any additional responsibilities assigned by the leadership