Vendor Qualification Manager II

Published
November 2, 2021
Location
Foster City, CA
Category
Job Type

Description

Job Details: Vendor Qualification Manager II

Work Location: Foster City, CA| Santa Monica, CA| Seattle, WA| Morris Plains, NJ

Duration: 12 months with the possibility of extension

Description

  • The Development Business Operations Vendor Qualification Manager will report to the Director,
  • Development Business Operations and is responsible for leading vendor qualifications in the clinical outsourcing of global Phase I-IV clinical trials, which may include clinical monitoring, data management, biostatistics, medical writing, Phase 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors. The Vendor Qualification Manager may also assist with other vendor assessments in the Development Business Operations group (i.e., IT Security Assessments, Anti-Bribery and Anti-
  • Corruption Due Diligence, etc.)
  • The Vendor Qualification Manager will manage the entire life cycle of vendor qualification, comprised of vendor pre-qualifications and vendor requalification's. Aspects of the vendor prequalification and vendor requalification processes include, but are not limited to: assembling and leading cross-functional vendor qualification teams, tracking requests, vendor services risk assessments, scheduling, maintaining an approved vendor services list, maintaining libraries of standards & VQ Questionnaires, planning remote or onsite vendor qualifications, notifying vendors, setting agendas, conducting vendor qualifications, leading evaluations, closing vendor qualification reports, and routine report outs for senior management.
  • The Vendor Qualification Manager will work with Vendor Outsourcing Managers, Vendor Selection
  • Teams and internal customers in the vendor qualification process and may assist with the planning of vendor capabilities presentations during the vendor bid defense meetings.
  • The Vendor Qualification Manager has executive presence; excellent communication, project management & critical thinking skills; and, is comfortable interacting with internal and external teams, such as, R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and vendors. Completes tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.
  • Demonstrates a thorough knowledge of Good Clinical Practice GCP, Good Pharmacovigilance
  • Practices GVP, Good Laboratory Practice GLP, Good Documentation Practice GDP and ICH E6 R2 compliance requirements. Demonstrates a thorough understanding of current global and regional trends in compliance. Candidate has 10+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA with 8+ years of relevant experience.

(1) PMP certification or equivalent certification,

(2) Candidates can be current or former project managers &

(3) Project management experience in Pharmaceutical or Healthcare industries

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