Your Impact:

The Senior Manager, Quality Assurance, will be a key member of the Quality team, leading quality assurance activities across both quality systems and GMP-focused operations to support the advancement of global Phase 3 clinical trials for RAP-219 and other assigned programs. This role will play a critical role in advancing and maturing the Quality Management System in preparation for commercialization, with a strong emphasis on GMP processes and procedures.

This position offers a unique opportunity to bridge GxP quality systems and hands-on GMP execution, supporting mission-critical activities such as batch record execution reviews while also driving continuous improvement across the broader quality framework. The ideal candidate is passionate about quality, embraces continuous improvement, and is eager to expand their QA expertise in a fast-paced, collaborative biotech environment that values learning, adaptability, and thoughtful risk-taking across various stages of clinical development. Success in this role requires comfort with ambiguity, a growth mindset, and the ability to learn from both successes and missteps while maintaining a strong commitment to quality and compliance.

Candidates may bring a strong foundation in either quality systems or GMP QA, with a demonstrated willingness to learn, grow, and develop proficiency across both areas.

Your Day-to-Day:

• 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.

Must-Haves:

• 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

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.


• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.


• Your perspective matters. Stick your neck out, share your ideas – we work as a team.


• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.


• Leadership that CARES – about you, your growth + development.


• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.


• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!


• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $165,000-185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.