Vendor Qualification Associate I

TekWissen ®; Foster City (CA); Hybrid; USD 100,289,000 - 117,482,000; Part time

Benefits offered by this job

Equal opportunity employer

Job summary

TekWissen Group is staffing a Vendor Qualification Associate I for a 12-month hybrid role in Foster City, CA. The position focuses on vendor capability assessments, sourcing, contracting, and inspection readiness across global R&D trials.

Ideal candidates will have a BS/BA with 5+ years of pharma/biopharma experience and PMP or equivalent certification. You will engage with multiple internal teams and external vendors to ensure data quality and compliance.

Qualifications

• BS or BA with 5 years of relevant experience.
• PMP certification or equivalent.
• Executive presence and excellent communication are required.
• Project management and critical thinking skills are essential.

Responsibilities

• Lead and support cross-functional efforts in vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness.
• Perform RFI, data privacy and security IT assessments, due diligence, financial health assessments, and inspection readiness activities.
• Develop data-informed insights and drive continuous improvement initiatives; deliver presentations and trainings.

Skills

Executive presence

Communication skills

Project management

Critical thinking

Stakeholder management

Vendor qualification

Education

BS/BA + 5 years

Job description

Location: Foster City, CA, 94404

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Hybrid

Shift: Monday - Friday From 8:00am To 05:00pm

Pay Rate: $35.00-$41.00/Hr

Overview

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Job Description

• Client is looking for a Vendor Qualification Associate I, who will report to the Director of Vendor Outsourcing.
• The candidate will be responsible for ensuring high quality of data and services across all vendors supporting Client s 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, 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.
• BS or BA with 5 years of relevant experience. PMP certification or equivalent certification

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 II 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.
• Candidate has 10+ years of relevant experience in the pharmaceutical or biopharmaceutical industry.
• Candidates can be current or former project managers & Project management experience in Pharmaceutical or Healthcare industries

TekWissen Group is an equal opportunity employer supporting workforce diversity.