Manager, Vendor Quality
- Location - NJ based team
- Position Hybrid
- 3 months to start-possible extension
- Pay - market rate
- 6-8 years' experience
- Looking for someone who's worked with CSV, GcLP, GCP, GLP space
- Experienced with following regulation: ICH GCP E6(r2) or FDA Parts 11, 50, 56, 312
- R&D clinical issue management experience required
- Clinical Operations and Clinical Quality experience is required
Description:
Reporting to the Director of R&D Vendor Quality within Research & Development Quality (RDQ), located at the Client Headquarters in Cambridge, MA, the contingent Manager will (i) Work with the RDQ and stakeholders to provide Quality support for Client's R&D Quality vendor program and drive continuous improvement of clinical, non-clinical and pharmacovigilance services to the Client 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 Client.
Responsible
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
Experience
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