Manager, Vendor QualityApply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Contract
Contract Length: 6+ Months
Job Summary: Reporting to the Director of Inspection Management within Research & Development Quality (RDQ) the contingent Manager will (i) Work with the Regulatory Intelligence team proactively monitoring, tracking, and analyzing global GCP regulatory updates from the industry (ii) Provide support to the inspection management team, aiding with administrative duties.
- Conduct ongoing review of GCP global regulatory intelligence information/feeds to determine relevance for the R&D organization. This includes monitoring, tracking and analyzing global GCP intelligence from various sources.
- Support the RDQ inspection management team with administrative tasks related to regulatory authority inspection logistics
- BS/BA, MS or PhD and a minimum of 6-8, 5, 2 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
- Working knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GCP regulations, guidelines and local legislation.
- Experience coordinating, and logistical planning for regulatory authority inspections
- 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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