Vendor Qualification Associate I
Hybrid: 2-3 days a week minimum. Either out of Foster City, CA or Santa Monica, CA
We are looking for a Vendor Qualification Associate, who will report to the Senior Manager of Vendor Outsourcing. The candidate will be responsible for ensuring high quality of data and services across all vendors supporting ours global R&D portfolio - Ph I-IV clinical trials.
The candidate should have a deep understanding of vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities as they will be leading and/or supporting those cross-functional efforts. The candidate should also have an understanding of various clinical trial activities such as clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
· Daily activities will include, but are not limited to, conducting Request for Information (RFI)
· Data Privacy and Security IT Assessments
· Anti-Bribery and Anti-Corruption Due Diligence
· Vendor Subcontractor Process Management
· Financial Health Assessments
· Inspection Readiness Preparation Activities
· Data Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement Initiatives, Presentations, and Trainings.
· Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.
· PMP certification or equivalent certification
· R&D Clinical Procurement Experience
· Candidates can be current or former project managers
· Possess a deep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries
· A plus would be a candidate with Vendor Qualification, Vendor Outsourcing & Vendor Contracting experience.
· The candidate should have executive presence, excellent communication skills, project management & critical thinking skills; and is comfortable interacting with internal stakeholders and external vendors.
· The Vendor Qualification Associate I will be regularly partnering with team members such as R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and vendors.
· The Vendor Qualification Associate I is expected to complete 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.