Director of Quality Assurance
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Director of Quality Assurance
Oxford UK Global remit IVD & NGS Technology
Oxford Nanopore Technologies (ONT) and Oxford Nanopore Diagnostics (OND) are looking for an exceptional Director of Quality Assurance to provide senior leadership strategic direction and operational excellence across our Quality function.
This is a pivotal leadership role for a highly experienced QA professional with deep expertise in IVD quality systems ISO 13485 and IVDR who thrives in complex cutting-edge technology environments.
The Role
Reporting to and acting as deputy for the Head of Quality Assurance you will lead and develop the QA organisation across ONT and OND ensuring full regulatory compliance while enabling business growth and innovation.
You will:
- Set strategic direction for Quality Assurance across RUO and IVD products
- Lead and develop a high-performing QA team across design manufacturing software and post-market activities
- Act as Management Representative for ISO 9001 and ISO 13485 and support PRRC responsibilities under IVDR
- Own and oversee QMS performance continuous improvement and audit readiness
- Ensure effective execution of CAPA change control batch release audits and post-market surveillance
- Partner closely with Regulatory Affairs on new product introductions filings and market expansion
- Represent Quality at senior leadership level and externally with auditors regulators and partners
About You
This is a senior non-negotiable experience requirement role. You will bring:
- 10 years experience leading full-lifecycle QA teams in the IVD industry
- Proven experience ensuring compliance with IVDR while supporting RUO product lines
- Deep working knowledge of ISO 13485 and IVDR (essential)
- Experience leading CE certification surveillance and unannounced audits
- Strong background across software assays reagents biologics microfluidics and complex instrumentation
- Experience implementing and managing electronic QMS and understanding computer systems validation
- Demonstrable leadership of multi-disciplinary QA teams (>5 people)
Highly desirable experience includes:
- FDA inspections and/or MDSAP audits
- Recall management and complex health authority interactions
- GAMP5 IEC 62304 IEC 14971 IEC 62366
- Global market entry and strategic quality planning
- Outsourced manufacturing or QMS activities
Why Join Oxford Nanopore
Youll be working at the forefront of next-generation sequencing shaping quality strategy for truly innovative technology that impacts research diagnostics and healthcare worldwide.
Interested Apply now or reach out for a confidential discussion.
Please note that no terminology in this advert is intended to discriminate on the grounds of a persons gender marital status race religion colour age disability or sexual candidate will be assessed only in accordance with their merits qualifications and abilities to perform the duties of the job.
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Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
Oxford Nanopore’s goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology enabling the real-time, high-performance, accessible and scalable analysis ... View more
