Clinical Quality Assurance Lead

ProPharma

Clinical Quality Assurance Lead overseeing quality management processes in pharmaceutical sectors. Driving positive change and ensuring regulatory compliance in quality activities.

Posted 4/17/2026full-time🇬🇧 United KingdomSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provides guidance for quality activities and drives positive change and process improvement
Performs, develops, manages, and executes quality management processes to ensure quality standards are maintained and compliant with regulatory requirements
Host and/or Support CRS/FSP client audit and/or regulatory authority inspection activities
Develop responses to CAPAs arising from client/inspections, as applicable to CQA
Collaborate with multiple lines of business to prepare for/conduct audits/inspections
Support CRS/FSP project leadership in setup and subscription of Client and/or project-specific Deviation, Quality Event, and CAPA eQMS reports for Client provision
Conduct periodic review of Deviation, Quality Event, and CAPA eQMS reports to facilitate identification of emerging trends
Escalate emerging trends to Management for improvement opportunities

Requirements

What you’ll need

University/Bachelor’s degree and/or appropriate relevant work experience
5 years’ Quality experience in pharmaceutical or medical device industries or other regulated industries (i.e., healthcare)
A minimum of 2 years’ experience hosting GCP audits required
Advanced computer skills including experience with Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams, etc.) and Adobe Acrobat application are required
Knowledge and experience in working with GxP QMS including but not limited to record management, reporting, and data analytics
Excellent verbal, written, presentation skills, and interpersonal communication skills with the ability to establish and sustain professional relationships with clients and internal staff
Ability to critically evaluate and troubleshoot complex problems with diligence while integrating stakeholder input and feedback
Exceptional time management, project management, delegation, multitasking, decision-making and problem-solving skills
Excellent attention to detail and commitment to quality

Benefits

Comp & perks

Flexibility to adapt and meet fluctuating business priorities
Must be willing to travel at least 5%, including internationally

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality management processesGCP auditsGxP QMSrecord managementreportingdata analyticsCAPADeviationQuality Eventprocess improvement

Soft Skills

verbal communicationwritten communicationpresentation skillsinterpersonal communicationcritical evaluationproblem-solvingtime managementproject managementdelegationmultitasking