Senior QA Auditor

Healx

Senior QA Auditor ensuring compliance with GCP and GMP standards at Healx. Leading analytical activities and collaborating with various teams to maintain quality assurance in clinical research and manufacturing.

Posted 5/27/2026part-timeCambridge • 🇬🇧 United KingdomSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead strong analytical, problem-solving activities to ensure compliance with clinical research (GCP) and manufacturing (GMP) standards
Work with the CMC Director to manage review of batch records and audit processes (internal, external, supplier)
Conduct deviation/CAPA investigations and root cause analyses
Prepare and manage documentation and change control, product release, ensuring adherence to regulations
Partner with Global Head of Clinical Development for strategic oversight and tactical execution of the Quality Management System (QMS)
Collaborate with CMC, Regulatory Affairs, Pre-Clinical and Clinical Operations personnel to improve QMS and product manufacturing

Requirements

What you’ll need

At least 7 years experience in pharma, biotech and/or CRO industries, preferably in both Clinical Research Operations and Quality Assurance
Bachelor’s degree in Science, Life Science or Health related field, or in Quality Management
Deep understanding of ICH-GCP and GMP guidelines, working knowledge of applicable EU directives/regulations, UK legislation and international clinical trial regulations
Strong analytical, problem-solving, and decision-making abilities
Process oriented and pragmatic
Excellent communication and interpersonal skills for leading teams and stakeholders
Willingness to travel to the US (once or twice a year)
Hands-on and collaborative approach to strong analytical, problem-solving
Experience with electronic Quality Management Systems (eQMS) (bonus)
Ability to work in cleanroom environments and experience of conducting GMP audits (bonus)

Benefits

Comp & perks

Competitive salary, share options, 7% employer pension contributions, life insurance of 4x base salary
Private medical insurance, 25 days annual leave (plus bank holidays) with the option to purchase additional days to support a healthy work-life balance, wellbeing support via Spill and our Employee Assistance Programme
Flexible and remote working options, home office set-up allowance, periodic in-person team days for company-wide collaboration and celebration
Enhanced family leave policies, miscarriage and fertility leave, flexible working practices
Personal learning and development budgets, regular personal development conversations and career support
One paid day off per year to volunteer for a cause aligned with our mission of supporting patients living with rare diseases; the opportunity to hear from and engage with patient groups and communities who offer us valuable insights into the experiences of those affected by rare diseases

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Hard Skills & Tools

GCPGMPdeviation investigationsCAPA investigationsroot cause analysisdocumentation managementchange controlQuality Management Systemclinical trial regulationsGMP audits

Soft Skills

analytical skillsproblem-solvingdecision-makingprocess orientedpragmaticcommunication skillsinterpersonal skillsteam leadershipcollaborationstrategic oversight