Description
The Quality Assurance and Vendor Management Associate supports the Associate Director of Quality and Compliance by overseeing the quality management system and acting as a GCP and regulatory compliance "gatekeeper." As Vendor Management Associate the job holder supports the selection, qualification, ongoing oversight, and performance evaluation of external vendors supporting Innovative Trials operations. This role ensures external service providers meet the company's quality and GCP standards and any risks related to outsourcing of the services are mitigated.
The Quality Assurance and Vendor Management Associate supports the Associate Director of Quality and Compliance by overseeing the quality management system and acting as a GCP and regulatory compliance "gatekeeper." As Vendor Management Associate the job holder supports the selection, qualification, ongoing oversight, and performance evaluation of external vendors supporting Innovative Trials operations. This role ensures external service providers meet the company's quality and GCP standards and any risks related to outsourcing of the services are mitigated.
Requirements
Education:
Degree educated, ideally in Life Science
Industry Experience:
Quality Assurance (QA):
Core Technical Competencies:
Education:
Degree educated, ideally in Life Science
Industry Experience:
- A solid background within clinical research, pharmaceuticals, biotechnology, or a contract research organisation (CRO) is highly preferred. Understanding GxP environments (GCP, GDP, GMP) is essential.
Quality Assurance (QA):
- Minimum of 2 years experience in Quality or Vendor/ Supplier Management role:
- Participating in quality audits, managing Corrective and Preventive Actions (CAPAs), tracking deviations, and contributing to standard operating procedure (SOP) management.
- Experience overseeing third-party vendors, tracking service level agreements (SLAs), evaluating vendor performance metrics, and participating in vendor qualification or selection processes.
Core Technical Competencies:
- Regulatory Knowledge: Familiarity with international clinical trial regulations and guidelines (such as ICH-GCP and relevant FDA/EMA/MHRA directives).
- Data & Documentation Systems: Proficiency working within Quality Management Systems (QMS) software and general electronic Trial Master File (eTMF) systems.
- Communication: Strong written and verbal communication skills. Assertiveness to constructively question status quo and ability to work in a multidisciplinary team.
- Adaptability: Excellent organisational and time management skills; able to prioritise in a fast-paced environment.
Quality Assurance and Vendor Management Associate employer: Innovative Trials
Innovative Trials in Letchworth is an exceptional employer that prioritises employee well-being and professional growth. With a strong focus on flexible working arrangements, competitive salaries, and generous leave policies, we foster a supportive work culture that encourages collaboration and innovation. Join us to make a meaningful impact in patient recruitment while advancing your career in a dynamic and rewarding environment.
