Rapport Therapeutics · 9 hours ago
Senior Manager, Quality Assurance
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$165K/yr - $185K/yr
8+ years expRapport Therapeutics is dedicated to developing precision neuromedicines to improve patients' lives through innovative science. The Senior Manager, Quality Assurance will lead quality assurance activities in support of global Phase 3 clinical trials, ensuring compliance with GMP processes and enhancing the Quality Management System.
BiotechnologyHealth CareLife ScienceMedicalNeurosciencePrecision Medicine
Responsibilities
Support quality oversight in a phase-appropriate manner across various GMP manufacturing activities including Drug Substance and Drug Product batch records, deviations, investigations, change controls, and analytical documentation (validation reports, stability protocols, etc.) to ensure compliance with applicable GxP requirements
Support the maintenance and continuous improvement of the Quality Management System (QMS), including: SOPs development and trainings, CAPA management (root cause analysis, implementation, etc.), Document control to maintain data integrity and traceability, Phase-appropriate quality risk management processes
Support inspection readiness activities and participate in internal audits, vendor audits, and health authority inspections, including preparation of responses and follow-up actions as needed
Support quality oversight of external vendors, CMOs, and service providers, including quality agreements, issue management, and performance monitoring
Apply quality risk–based thinking to identify, assess, and proactively mitigate quality and compliance risks across GMP operations and quality systems
Partner with Manufacturing, Technical Operations, Clinical Operations, and Supply Chain teams to ensure quality requirements are integrated into day-to-day operations and program timelines
Contribute to the evolution of QA processes and best practices to support Phase 3 execution and readiness for commercialization
Qualification
Required
Bachelor's degree in life sciences or related discipline
8+ years of experience in a Quality Assurance role with a focus on GMP QA and/or quality systems
Proven QA experience in an environment with Phase 3 global trials
Strong working knowledge of QA principles and global regulations and guidances
Ability to work collaboratively in a fast-paced, dynamic work environment, while managing multiple priorities
Proficient working knowledge of electronic quality management systems and the available metric/reporting functionality
Experience in QA environments for both early-phase and late-phase clinical programs
Proactive, self-motivated, and naturally curious QA professional who views challenges and deviations as opportunities for learning and improvement
Strong interpersonal skills and alignment with Rapport's values and company culture
Benefits
Unlimited PTO
Lifestyle spending account
Commuting reimbursement
Competitive benefits
Company
Rapport Therapeutics
Rapport Therapeutics is a clinical-stage biotechnology company that discovers and develops precision medicines for neurological disorders.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$500MKey Investors
Cormorant Asset ManagementThird Rock Ventures
2025-09-09Post Ipo Equity· $250M
2024-06-07IPO
2023-08-23Series B· $150M
Leadership Team
Troy Ignelzi
Chief Financial Officer
Cheryl Gault
Chief Operating Officer
Recent News
2026-01-08
Company data provided by crunchbase