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Manager, Vendor Quality
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Location: Cambridge, Massachusetts 02139
Employment Type: Contract
Job Description
Contract Length: 6 months with possible extension or conversion
Job Summary: This person will 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.
Responsibilities:
Requirements:
Job Summary: This person will 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.
Responsibilities:
- 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
Requirements:
- 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
- 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
Christian Griffith
Principal RecruiterCan't find your fit?
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