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 maintenance of Respivant’s Quality System for all GxP areas
• Oversee the development and implementation of Phase-appropriate QA strategy covering cGMP/QSRs (drug and device) 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,), including qualification, auditing, and on-going Quality Management
• Perform batch reviews and release of Clinical Trial Materials (CTM)
• Write SOPs, conduct and document training
• Lead the effort to achieve “Inspection Readiness” for GMP and GCP areas
• Lead QA support during internal and external audits
• Review technical documents and agreements from QA perspective

Candidate background and experience:
• 10 years of experience initiating and implementing Quality Systems, focused on investigational pharmaceutical products
• 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