Permanent Position · Senior

Senior Quality Assurance Specialist

The candidate will provide experienced QA support and oversight to manufacturing operations for a clinical-stage gene therapy company. This role ensures regulatory compliance and product quality requirements are met while facilitating timely product release. The successful applicant will coach the QA team, manage the Quality Management System, and drive continuous improvement across local quality processes. Key focus areas include batch documentation review, root cause analysis, and supporting regulatory audits within a sterile GMP environment.

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Opportunity overview

Opportunity type
Permanent Position
Required seniority
Senior
Work location
Onsite
Location
United Kingdom
Start
ASAP
Duration
Permanent
Travel
—

Required role

PLM ConsultantSystem Configuration Specialist

Required platforms

eQMSMicrosoft Office

Required skills

Quality Management System (QMS)GMP ComplianceCAPAChange ControlRoot Cause AnalysisInternal AuditingBatch Record ReviewRisk Assessment

Required industry experience

Life Sciences & PharmaBiotechnologyMedical Devices & Lifesciences

Responsibilities

  • Provide QA oversight to manufacturing operations and supporting functional areas.
  • Manage the Quality Management System (QMS) including generation and approval of GMP documentation.
  • Review batch documentation to ensure timely release of compliant products.
  • Perform internal audits, inspections, and detailed audit reporting.
  • Investigate deviations, CAPAs, OOS results, and manage change controls and risk assessments.
  • Deliver compliance training to operational teams and provide guidance on quality issues.
  • Support facility walk-rounds and provide direct assistance during customer and regulatory audits.
  • Maintain QA KPI metrics and support document management activities.

Requirements

  • Minimum 5 years of experience working within a sterile GMP manufacturing environment.
  • Extensive experience in Compliance and Quality Assurance roles.
  • Strong understanding of Quality Management Systems and regulatory requirements.
  • Proficiency in Microsoft Office and experience using electronic QMS (eQMS) databases.
  • Proven track record in handling regulatory inspections and client audits.
  • Demonstrated ability in root cause analysis and data-driven decision making.
  • Excellent interpersonal skills and ability to work both independently and as a team player.
  • Strong organizational skills with a high level of attention to detail.