Respivant is a clinical stage company developing products for the treatment of rare diseases using a combination drug/device product.  We are seeking a seasoned person who can lead the QA function and provide Quality oversight at Respivant. 

Position requirements:

  • Oversee the development, implementation, and maintainenance of Respivant’s Quality Management System for all GxP areas
  • Oversee the development and implementation of Phase-appropriate worldwide QA strategy covering cGMP/QSRs (drug and device) , GLP and GCP
  • Ensure compliance of the Quality Management Systems with the Quality Management standards of our parent company, Roivant
  • Oversee supplier and vendor management (CMOs, CROs, IRT/IVRS providers), including qualification, auditing, and on-going Quality Managment
  • Lead QA support during internal and external audits, regulatory inspections and due diligence
  • Review technical documents and agreements from QA perspective  

 

Candidate background and experience:

  • 5-10 years of experience implementing worldwide Quality Management Systems, focused on investigational pharmaceutical products
  • Track record of successful interactions with FDA and European Regulatory Authorities
  • Experience with developing phase-appropriate QA strategy that would be compliant with US and EU requirements, and successfully implementing it
  • Experience with Quality Systems relating to the development of a drug/device combination product would be highly desirable
  • Experience working in a virtual environment

 

Education and skills

  • BS/MS/PhD in a Science or related filed
  • Highly productive in a team environment working with an open mind and incorporating others’ input in planning and implementation
  • Flexible in approach to identify solutions that meet all Quality requirements yet are least burdensome
  • Excellent communication – both oral and written
  • Functionally efficient in the high-paced environment typical of early stage companies.
  • Willing to span the range of engagement from strategic thinking to hands-on drafting of quality documents

Please submit your resume to: careers@respivant.com