Manager/Senior Manager, Clinical Quality Assurance

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we're doing this with extraordinary science and awesome people (affectionately called Rapptors).

Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder.

The strength of Rapport comes from our Rapptors - who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you're as excited about this opportunity as we are!

Your impact:

• This Manager/Senior Manager of Quality Assurance role is responsible for supporting in the oversight and management of on-going clinical trials and ensuring GCP quality compliance with global laws, regulations, and applicable guidance.
• The overall responsibility of this role is to support in ensuring compliance in Good Clinical Practice (GCP) and clinical trial activities via service provider (vendor) management.

Your day-to-day:

• Ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, vendors, and processes in relation to GCP/ clinical trials.
• Support in quality event escalation and remediation amongst internal GCP groups and external third-party vendors.
• Ensuring quality compliance and oversight in the day-to-day clinical trial activities/ studies.
• Serve as quality representative at internal CST and external CRO clinical study meetings.
• Support and/or perform GCP Vendor qualification/re-qualification audits
• Perform Clinical Site audits
• Support and manage execution of internal, eTMF, and CSR audits
• Assist in development of GCP procedures, periodic reviews, and process optimization
• Initial point of contact for any GCP related inquiries from CST members

Must-Haves:

• Manager is 6+ years, and Sr. Manager has 8+ years' experience.
• Bachelor's degree in Life/Health Sciences
• Strong familiarity with ICH E6 (R2) Good Clinical Practice requirements and GCP (R3) implementation.
• Knowledge of Quality Assurance principles, concepts, industry practices, and standards
• Experience with clinical study platforms including but not limited to - eTMF, EDC, eCOA, IRT, etc.
• Experience in participating in and overseeing GCP audits; experience including external CRO, clinical/regulatory and document auditing desirable.
• Experience in all phases of regulatory submissions and interactions; international experience preferred. Require minimal experience with mid/late phase clinical trial organizations.
• Experience in clinical trials with small molecules
• Strong communication and the ability to collaborate effectively across the organization.
• Demonstrated diplomacy, active listening, and a problem-solving mindset to foster a culture of continuous team-based improvement.
• Hybrid position with 1+ day per week in Boston office
• Ability to travel to clinical vendors/ clinical study site collaborators (up to 10%)

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 $130,000 to $150,000 (Manager level) or $150,000 to $175,000 (Senior Manager level). 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.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

CCPA disclosure notice can be found here.