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Sr Clinical Quality Assurance Auditor – REMOTE
Join Beacon Therapeutics (USA) Inc as a full-time Sr Clinical Quality Assurance Auditor and take your career to the next level with a fully remote position based on the East Coast. You’ll have the opportunity to leverage your experience in a forward-thinking biotech environment that values accountability and continuous improvement. Collaborate with a diverse team of professionals committed to making remarkable things happen, all while working in a transparent and respectful culture.
Your expertise will contribute to ensuring the utmost quality in clinical practices, making a tangible impact on our mission. With competitive pay based on education and experience, this role offers the perfect balance of professional growth and flexibility. You will be provided great benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, Employee Discounts, and Employer paid STD & LTD. Embrace this unique opportunity to shape the future of biotechnology while working from the comfort of your home.
Beacon Therapeutics (USA) Inc: What drives usIf you are passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We are a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.
Make a difference as a Sr Clinical Quality Assurance AuditorAs a Sr Clinical Quality Assurance Auditor at Beacon Therapeutics (USA) Inc, you will proficiently conduct Good Clinical Practice (GCP) audits of Clinical Sites, Trial Master Files, and Clinical Vendors, ensuring compliance and excellence in clinical operations. Your role will involve evaluating and tracking quality issues, as well as implementing corrective and preventive actions to enhance our processes. By effectively supporting our internal customers in Clinical Development and Clinical Operations, you will play a critical part in fostering a culture of accountability and continuous improvement. Your expertise will not only help maintain the highest standards of quality but also drive collaboration across teams, solidifying our commitment to integrity and innovation in the biotech industry.
Requirements for this Sr Clinical Quality Assurance Auditor jobTo succeed as a Sr Clinical Quality Assurance Auditor at Beacon Therapeutics (USA) Inc, candidates should possess a robust set of skills and experiences tailored to the demands of the role. Proficient clinical audit experience with Investigator Sites and Trial Master Files (TMF) is essential, along with a strong understanding of Good Clinical Practice (GCP) and US/EU regulations. The ideal applicant will demonstrate proven experience in auditing investigator sites and clinical vendors, showcasing an ability to effectively evaluate and manage issues and CAPAs.
A collaborative spirit is crucial, as you’ll provide responsive customer support to internal departments. Additionally, the ability to work professionally and independently in a remote environment is vital, alongside critical thinking skills for navigating complex, ambiguous situations. Strong written and verbal communication abilities will enable you to clearly articulate observations.
Knowledge of gene therapy is preferred, further enriching the expertise you bring to our innovative team.
Knowledge and skills required for the position are:
- Clinical Audit Experience with Investigator Sites, TMF, Vendors
- Effectively Evaluate and Manage Issues and CAPAs
- Collaborative and responsive customer support to internal departments
- Good Clinical Practice and US/EU Regulations
- Proven experience auditing investigator sites and clinical vendors
- Ability to work professionally and independently in a remote environment
- Critical thinker with the ability to navigate gray areas
- Strong written and verbal communication skills to clearly and effectively explain observations
- Gene therapy knowledge preferred
If this sounds like the right job for you, don’t wait – apply today to join our team. We look forward to hearing from you!

Senior Clinical Scientist – Remote
Join Beacon Therapeutics (USA) Inc as a Senior Clinical Scientist (REMOTE) and immerse yourself in cutting-edge biotech research that is shaping the future of healthcare. This fully remote position allows you to collaborate with a diverse team of forward-thinking professionals committed to making remarkable advancements in clinical science. Your expertise will play a crucial role in driving critical projects, facilitating continuous improvement, and enhancing patient outcomes.
At Beacon Therapeutics, accountability and integrity are at the heart of our work culture, empowering you to make impactful contributions from anywhere. Embrace the opportunity to work collaboratively and transparently with talented individuals who share your passion for innovation. You can get great benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, Employee Discounts, and Employer paid STD/LTD. If you are ready to take the next step in your career and drive meaningful change, we encourage you to apply today!
Hello, we’re Beacon Therapeutics (USA) IncIf you are passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We are a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.
What would you do as a Senior Clinical ScientistAs a Senior Clinical Scientist at Beacon Therapeutics (USA) Inc, you will play a pivotal role in advancing our innovative clinical programs. Collaborating with cross-functional teams, you will design, execute, and analyze clinical trials, ensuring the highest standards of data integrity, regulatory compliance, and scientific rigor. Your expertise will support protocol development, safety monitoring, and the interpretation of medical data, while also driving pharmacovigilance activities. This multifaceted position offers you the chance to influence trial outcomes and contribute to groundbreaking research that enhances patient care and therapeutic effectiveness.
Join us and be part of a professional team dedicated to making remarkable achievements in the biotech industry.
Does this sound like you?To excel as a Senior Clinical Scientist at Beacon Therapeutics (USA) Inc, you will need a robust skill set that aligns with our commitment to scientific excellence. A strong foundation in clinical regulatory and pharmacovigilance knowledge is essential, along with a solid understanding of clinical trial design and regulatory requirements, including GCP and ICH guidelines as set forth by the FDA and EMA. Your analytical and data interpretation skills will enable you to review, clean, and interpret complex clinical and safety data effectively. Furthermore, the ability to collaborate and communicate across cross-functional teams, including medical affairs, clinical operations, biostatistics, and regulatory and safety departments, is critical.
You will be expected to present clinical findings and engage in scientific discussions with both internal and external stakeholders, ensuring that our studies uphold the highest standards of integrity and rigor.
Knowledge and skills required for the position are:
- Strong clinical regulatory and pharmacovigilance knowledge
- A solid understanding of clinical trial design
- Working knowledge of GCP ICH guidelines regulatory requirements (FDA, EMA) and pharmacovigilance principles to support protocol development, data analysis, and AE reporting.
- Analytical and data interpretation skills with ability to review, clean, and interpret clinical and safety data.
- Cross-functional collaboration and communication – a strong ability to work with medical affairs, clinical operations, biostatistics, regulatory, and safety, effectively presenting clinical findings and supporting scientific discussions with internal and external stakeholders.
If you believe that this position matches your requirements, applying for it is a breeze. Best of luck!
