Healx
Senior QA Auditor - 60% - 80%
Cambridge · Senior · Part-time
Sponsorship not specifiedDetected 63 days ago
GCPExcelAuditingSupply ChainClinical TrialsClinical ResearchPharmacologyGMPFDA RegulatoryResearchCommunicationCollaborationProblem SolvingRegulatory Affairs
About the role
- They will ensure all clinical research activities at Healx complies with GCP standards, SOPs, and international regulations, execute Healx's annual audit plan, and
- The GMP aspect of this role involves ensuring Healx's investigational products meet strict GMP standards through Healx's QMS management.
Responsibilities
- Manage GMP documents, review and co-approve batch records, and ensure proper control and archiving of quality-related data
- Work closely with Regulatory Affairs to ensure that all manufacturing and clinical activities remain in strict alignment with current regulatory filings (e.g., IND, CTA, or MAA) and to support the preparation of regulatory submissions
- Develop, write and maintain company SOPs in accordance with industry expectations, ICH-GCP and GMP guidelines and regulations where Healx operates
- Maintain and improve Healx's Quality Management System (QMS), including delivery of training and tracking of training across company, change control (including regulatory impact assessment in coordination with Regulatory Affairs), deviations, CAPAs, and risk assessments, in cooperation with the management team (MT), department directors and with support from the Clinical Team
Requirements
- You have at least 7 years experience in pharma, biotech and/or CRO industries, preferably in both Clinical Research Operations and Quality Assurance, and you're now looking for your next step up.
- You are excited about taking on new challenges and responsibilities in a mission-driven startup.
- Deep understanding of ICH-GCP and GMP guidelines, working knowledge of applicable EU directives/regulations, UK legislation and international clinical trial regulations (e.g., EU GMP, US FDA cGMP)
- Ability to work in cleanroom environments and experience of conducting GMP audits
Nice to have
- Experience with electronic Quality Management Systems (eQMS)
Compensation
- Prepare and execute the annual audit plan (scope to include compliance with QMS, external audits at investigational sites and third-party vendors) and in ensuring vendors maintain their qualification
Benefits
- Verify that batch documentation and product specifications comply with the 'Approved' versions filed with Health Authorities before final certification or release
This listing is sourced directly from Healx's careers page and normalized into a canonical job model.