logo

View all jobs

Associate Director, Clinical Quality Assurance

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

About the role

The Associate Director of Clinical Quality Assurance will be responsible for the management, execution, and continuous improvement of Vedanta’s GCP and GLP compliance programs, its CROs, and Investigator Sites. The person filling the role will ensure quality execution of Vedanta’s clinical programs throughout the clinical development lifecycle. This individual will also interact with internal and external stakeholders and be the Quality Assurance representative to clinical teams. We are open to motivated candidates who want to work fully remotely instead of relocating.

Here’s What You’ll Do:

  • Develop, implement, and maintain GCP Quality Systems, Policies, and SOPs.
  • Implement GLP oversight and procedures as needed.
  • Maintain and execute an audit program for internal processes, clinical investigator sites, CROs, TMFs, and laboratories.
  • Support inspection readiness initiatives.
  • Review and approve GCP study protocols, reports, and documents.
  • Identify Quality- and Compliance-related issues and collaborate with Clinical Research to implement practical solutions in a strategic and proactive manner.
  • Participate in Clinical Research meetings as the Quality Assurance representative.
  • Train and mentor staff on global GCP regulations and guidelines.
  • Periodically report the state of GCP Quality and Compliance metrics and initiatives to senior management.

Requirements:

  • Bachelor’s degree in a scientific discipline or a related field.
  • A minimum of 10 years relevant industry experience in sponsor companies, CROs, or GCP consulting.
  • Expert knowledge of EU and US FDA regulatory landscape and trends and application in global, late phase clinical trials.
  • Prior experience managing and leading GCP audits.
  • Direct experience with regulatory submissions and inspections.
  • Strong communication, leadership, organizational, and problem-solving skills.
  • Ability to work in a fast-paced setting and adjust to a changing environment.
  • Must be able to travel as needed to conduct QA audits.

Why join Vedanta Biosciences

Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

Our Vision:

We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia

Powered by