Quality Assurance and Vendor Management Associate in Letchworth

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.

Key Responsibilities

• Quality Assurance Support:
• CAPA Management: Independently manage and maintain the corporate CAPA Log. Proactively partner with and hold action owners accountable to ensure the timely progression and closure of corrective actions.
• Change Control: Guide and support cross-functional colleagues through the Change Control process; ensure the Change Control Log remains current, draft quality-related changes, and actively drive closure and effectiveness assessments.
• Quality Events (Client Complaints/Internal Non-conformances): Coordinate and lead investigation meetings for Quality Events; collaborate on root-cause analysis and technical report writing, secure formal sign-offs, maintain the QE Log, and independently identify and implement necessary CAPAs.
• Controlled Documents (CDs Lifecycles): Own the end-to-end Controlled Document review and publication workflow; pre-advise authors on upcoming reviews, drive follow-ups to prevent lapses, and structurally maintain the Google Drive CD architecture and CD Matrix in strict compliance with GCP.
• Quality Review & Data Analytics: Partner directly with the Associate Director (AD) to analyse quality metrics, track trends as per SOP, and prepare high-level data insights and presentations for Quality Review Meetings.
• Risk Management & Assessment: Author comprehensive standalone risk assessments and strategically integrate risk-based thinking into existing operational workflows.
• Audit & Inspection Readiness: Coordinate internal audit documentation and act as a key support pillar during internal and client audits to ensure continuous company readiness.
• Software and System Validation: Provide strategic guidance to cross-functional teams throughout the procurement and validation lifecycle of new software solutions, ensuring rigorous adherence to internal SOPs and quality standards.
• Client Relations and Audit Support: Act as a primary liaison for client inquiries and formal RFI submissions; diligently track post-engagement action items and coordinate all logistical requirements for client-led quality audits when necessary.
• QA Archiving & Governance: Oversee and maintain the integrity of the Quality Assurance Archive; provide day-to-day, self-led guidance to wider business units to champion adherence to company procedures and international GCP standards.
• Vendor Onboarding: Execute the end-to-end review of prospective service providers for operational excellence.
• Strategic Needs Assessment: Proactively collaborate with functional leaders to determine and define vendor requirements at specialized organizational levels.
• Performance Metrics & Service Improvement: Rigorously monitor supplier performance and identify strategic opportunities to enhance external service delivery.
• Lifecycle Governance: Maintain the corporate Approved Vendor List; manage the cyclical re-qualification process and provide comprehensive support during supplier audits.
• Governance Engagement: Facilitate and lead scheduled Governance Meetings with priority operational partners to ensure alignment.
• Risk mitigation: Effectively deploy new areas of assessment, related to new and existing threats e.g. cybersecurity, changes of regulations and AI governance.
• ESG Compliance: Champion environmental and social responsibilities by verifying adherence within the key vendor network.
• Environmental, Social and Governance Program: Liaise with the stakeholders to improve the existing ESG program. Communicate performance through KPIs, employee awareness, etc. Monitor and report Scope 1, 2, and 3 emissions for the project and investigate discrepancies.

Key Skills/Attributes/Education

• Education: Degree educated.
• Industry Experience: A solid background within clinical research, pharmaceuticals, biotechnology, or a contract research organization (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.
• 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 question status quo constructively and ability to work in a multidisciplinary team.
• Adaptability: Excellent organizational and time management skills; able to prioritise in a fast-paced environment.