Manager, Vendor Quality
200 Technology Square REMOTE, MA 00000 US
Job Description
Target PR Range: 50-85/hr
*Depending on experience
The Role:
Reporting to the Director of R&D Vendor Quality within Research & Development Quality (RDQ), located in Cambridge, MA, the contingent Manager will (i) Work with the RDQ and stakeholders to provide Quality support for the R&D Quality vendor program and drive continuous improvement of clinical, non-clinical and pharmacovigilance services to the R&D 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 the company.
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
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