The Vendor Manager Associate plays a key role in our Vendor Quality and Qualification team in supporting the qualification of third-party clinical vendors. This position will be responsible for supporting the process in the qualification and requalification of third-party vendors, who provide services/ products that directly support clinical trials.
Responsibilities
- Supports the vendor qualification process for Fortrea clinical vendors, including the assessment of capabilities under the direction of the Manager-level or higher in Vendor Quality and Qualification
- Coordinates the qualification process with SMEs for QA, Clinical Sourcing, functional area SMEs, etc, maintaining effective tracking of the process and completion in a timely manner
- Includes issuance, collection and review of vendor qualification documents i.e. CDA, DDF and RFI and ensuring proper follow up on vendor qualification requests
- Partner with QA department in vendor qualification audits
- Creation/ maintenance of Qualified Supplier List (QSL). Ensures the QSL is maintained and provides clear information on the available approved vendors
- Ensure the maintenance of accurate and complete vendor files, ensuring documentation is available for QA, Clinical Sourcing, compliance and clinical audits
- CAPA/ audit support
- Participates in and supports other CVS initiatives as required
Requirements
- Bachelor's degree in Life Sciences
- 3+ years of experience in the life sciences industry e.g. CRO, pharma, biotech and experience in the job discipline (vendor qualification/ vendor management/ QA) is preferred
- Experience in clinical research, understanding of clinical research, and comprehensive knowledge of clinical trial services and vendors
- Experience working independently with minimal supervision and in a team environment under time and resource pressures
- Excellent interpersonal, oral and written communication skills when dealing with both external and internal customers with an ability to prioritize and meet deadlines
- Good presentation skills
- Proficient with MS Office programs
- Proactive self-starter
- Multi-tasker
- Creative problem solver (to improve processes, create new approaches)
- Excellent Project Management skills to ensure proper proactive planning and follow up
- Well Organized
- Team player
- Enthusiastic agent of change
Learn more about our EEO & Accommodations request here.