Voronoi, Inc. Clinical Quality Assurance; QA​/Hybrid

[Voronoi, Inc.] Clinical Quality Assurance (QA) / Hybrid Work

Location: Greater Boston, MA (Hybrid, minimum 2 days onsite per week)

Reports to: Chief Medical Officer

Employment Type: Full-time

Experience Level: 5+ years (Senior to Director)

Founded in 2015, Voronoi, Inc. (KOSDAQ:310210) is a clinical-stage biopharmaceutical company developing innovative, precision-targeted therapies in oncology. Operating across the U.S. and South Korea, we combine translational research, structure-based drug design, and data-informed development to advance next-generation treatments that address critical unmet needs for patients with oncologic diseases.

We are seeking a detail-oriented Clinical Quality Assurance (QA) professional to support quality and compliance activities across in-house oncology clinical development programs. This role will contribute to maintaining and improving the Clinical Quality Management System (QMS) and ensuring that clinical trials are conducted in compliance with GCP, regulatory requirements, and internal standards. The individual will work closely with Clinical Operations and cross-functional teams to support audit readiness, quality oversight, and continuous process improvement in a fast-paced biotech environment.

Quality Systems and Compliance

• Support maintenance and continuous improvement of the Clinical Quality Management System (QMS)
• Assist with SOP development, revision, and document lifecycle management
• Ensure compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements

Audit and Inspection Readiness

• Assist in planning and execution of internal and external audits (sites, vendors, CROs)
• Support audit documentation, findings tracking, and CAPA activities
• Contribute to inspection readiness efforts across clinical programs

  CAPA and Quality Oversight

  • Track and support CAPA development, follow-up, and closure
  • Partner with Clinical Operations to ensure quality oversight across ongoing clinical trials
  • Support risk identification and quality issue resolution

  Clinical Trial Support

  • Support development of clinical processes, tools, and study documentation
  • Ensure quality and consistency of clinical trial documentation
  • Assist with TMF quality review and oversight

  Training and Systems

  • Support development and delivery of GCP and QA-related training materials
  • Utilize and maintain systems such as eQMS, CTMS, and eTMF
  • Ensure accurate tracking and documentation within applicable systems
  [Qualifications]
  • Bachelor’s degree in life sciences or related field preferred
  • 5+ years of experience in early to mid-stage clinical development transition and ICH guideline compliance
  • Exposure to QA, QMS, audits, or SOP development preferred
  • Working knowledge of GCP and clinical trial processes
  • Strong organizational skills and attention to detail
  • Ability to manage multiple tasks in a fast-paced environment
  • Strong problem-solving and communication skills
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint)
  • Familiarity with CTMS, eTMF, or eQMS systems preferred
  [Additional Information]
  • Hybrid work environment (minimum 2 days onsite in Waltham, MA office)
  • Flexible work hours to support collaboration across global teams
  [Why Voronoi]

  Join a dynamic oncology biotech where your scientific expertise directly contributes to advancing first-in-class therapies for patients with oncologic diseases worldwide. At Voronoi, we value collaboration, integrity, and curiosity — and we empower every team member to make a meaningful impact.

  Voronoi is proud to be an equal opportunity employer. We are committed to fostering a diverse and inclusive workplace where every individual is valued, respected, and empowered to contribute to our shared mission of advancing transformative oncology therapies. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by applicable law.