Quality Assurance Manager

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About the job

Do you have significant experience in Quality Assurance within the injectable space? Are you looking for a change of environment?

Invenia Group is partnered with a clinical-stage vaccine development company focused on the design and development of preventative and therapeutic injectables. Our client is looking for a Quality Assurance Manager to join their rapidly expanding business.

Role responsibilities:

If successful, you will focus on overseeing and approving cGMP and GCLP/GLP activities carried out internally and externally as well as managing cGMP Compliance levels at contractor sites.

You will also be responsible for the following:

  • Measuring and monitoring cGMP Compliance levels through auditing at contractor sites
  • Reviewing and approving cGMP documentation and master batch records – including QA Agreements, investigations, Out-of-Specification results, product development, and validation reports
  • Reviewing and approving executed production batch records and providing disposition to CTM materials
  • Managing quality investigation activities at CMOS
  • Direct responsibility and accountability for all Quality oversight activities relating to preclinical and clinical assay testing
  • Providing quality oversight to execution of pre-clinical and clinical assay testing – review and approval of analytical instrument and equipment and validation protocols and reports, analytical instrument and equipment, IOQ/PQ and calibration activities, etc

What we are looking for:

Someone with at least a scientific Bachelor’s degree (Master’s/PhD is desirable) and over three years of experience within the pharmaceutical/vaccine industry. They must have hands-on experience with the development, implementation, and maintenance of quality systems supporting clinical assay testing. A background in immunology, microbiology, and/or virology is essential for this position.

If you are interested in proceeding with this opportunity, please apply to find out more.