Clinical Quality Specialist

TL;DR

Clinical Quality Specialist (GxP): Supports delivery of clinical services ensuring compliance with quality and regulatory requirements with an accent on monitoring quality systems, handling deviations, CAPAs, and data analysis. Focus on investigating quality events, performing effectiveness checks, tracking KPIs, and supporting audits and inspections.

Location: Supports remote working worldwide; hybrid encouraged for those within short commute of offices in North Yorkshire (UK), Ireland, United Kingdom, Netherlands. No advantage or disadvantage based on office proximity.

Company

hirify.global provides end-to-end consulting solutions across regulatory sciences, clinical research, quality & compliance, pharmacovigilance for biotech, medtech, and pharma organizations.

What you will do

• Generate reports on quality activities, analyze and investigate deviations and quality events to identify improvements.
• Review, approve, and communicate root causes and corrective actions to stakeholders.
• Develop, recommend, and monitor corrective and preventive actions (CAPAs).
• Collect, manage, and analyze data on CAPAs, deviations, and quality KPIs; track documentation and audit findings.
• Support external client audits or regulatory inspections by preparing reports and gathering documents.
• Perform effectiveness checks on deviations and quality events; facilitate eQMS activities like document management and change control.

Requirements

• University/bachelor's degree or equivalent relevant experience.
• Minimum 2 years in Quality Assurance role with deviation, CAPA, and effectiveness check handling.
• Awareness and compliance with Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), Good Documentation Practices (GDP).
• Analytical skills to gather/interpret data, identify trends/outliers; excellent written/verbal communication.
• Proficiency in Microsoft Word and Excel; ability to prioritize, organize data tracking with attention to detail.
• Proactive, works independently with minimal supervision.

Nice to have

• Knowledge/experience with GxP Quality Management Systems (record management, reporting, data analytics).

Culture & Benefits

• Supports remote working with hybrid option near offices for in-person collaboration as agreed.
• Commitment to diversity, equity, inclusion; safe space for authentic self and innovation.
• Equal Opportunity Employer; all applications personally reviewed by recruitment team, no AI screening.