Manager, Vendor Quality Jobs

Manager, Vendor Quality

$50.00-$85.00 per hour

100% Remote

Temp through the end of the year

The Role:

Reporting to the Director of R&D Vendor Quality within Research & Development Quality (RDQ), located at the Headquarters in Cambridge, MA, the contingent Manager will (i) Work with the RDQ and stakeholders to provide Quality support for R&D Quality vendor program and drive continuous improvement of clinical, non-clinical and pharmacovigilance services to the organization. You will work with internal business partners and alignment with business expectations, GxP standards and other applicable regulatory requirements. The Manager will also partner with R&D to create a quality culture within Moderna.

Here’s What You’ll Do:

 Support strategic initiatives by leading projects to design and deploy process and technology related improvements and monitoring of R&D vendor issues for trends across the operational areas

 Develop and write vendor issue procedures

 Support in developing establishing metrics and KPIs for R&D vendor issues

 Define and develop quality agreement process with R&D vendors

 Process vendor requests

 Quality checks of vendor quality documents

 May participate in GCP, GLP, or GVP audits

Here’s What You’ll Bring to the Table:

 BS/BA in life sciences and a minimum of 6-8 experience in Biotech, Pharma or Vaccine Industry

 Working knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GCP

regulations, guidelines and local legislation

 Auditing experience in GCP, GLP, or GVP preferred

 Excellent communication skills

 Strong interpersonal skills and ability to effectively interact with all levels with the organization

 Ability to work independently and within a team environment

 Ability to manage multiple projects in a fast-paced environment

 Ability to collaborate effectively in a dynamic, cross-functional matrix environment