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Manager, Quality Assurance, Quality Regulatory Submissions

Manager, Quality Assurance, Quality Regulatory Submissions

We are looking for a key new member to our gene therapy approach. This role will include the interpretation and monitoring of cGMP regulatory guidelines, as well as trends in the fast moving ATMP regulatory space. You will support the creation of CMC sections of major regulatory investigational product as well as commercial submissions as response to HA queries. You will also assure that those queries are both scientifically accurate and complete, with a high quality and are presented in a manner that facilitated both internal and agency review. You will be responsible for the process team's understanding of and compliance to regulations specific to the market. You will also be responsible for being the driving force behind continuous improvement and standard practices for quality to not only get to top performance, but also consistency. You will need to be able to give Quality experience to teams working on the development and implementation of novel quality pathways for all aspects of the manufacturing process. Plasmids, starting materials, lentiviral vector, to name a few.

Requirements

  • Minimum of 6+ years of experience in the biologics industry

  • Experience in quality, technical, and/or regulatory roles supporting programs in pre-clinical phases.
  • 2+ years in Quality (QC,QA and/or Compliance)
  • BA and/or MA within a scientific discipline
  • A understanding of manufacturing and drug product development, as well as a technical understanding of biopharmaceutical production
  • Should be proficient in giving a quality analysis of moderate to of issues both moderate and complex.
  • Will need to have the ability to balance multiple priorities in a fast- paced environment while pushing a culture of quality and continuous improvement.
  • You will need strong project management skills as well as the ability to communicate effectively across matrix functions, while making an influence on areas not under direct control to obtain shared objectives
  • Must be able to do all of that while balancing quality, speed, and risk.

Sthree US is acting as an Employment Business in relation to this vacancy.