Director of Quality Assurance

Job Summary

Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop, manufacture, and sell products based on ONT’s unique and market leading nanopore-based next generation gene‑sequencing (NGS) technology. In addition to selling its technologies and products into research use only applications, the firm also markets IVD instruments (using the same highly complex, unique NGS technology). ONT also develops its own assays and reagents and directly collaborates with a wide range of third parties to support the development of assays by those parties.

Design and manufacturing are based in Oxford but the firm’s products are marketed globally (into both RUO and IVD markets). Consequently, the firm’s IVD instruments and assays are subject to regulations in the territories in which they are sold and regulatory filings must be made to the relevant health care authorities. To ensure that products conform with relevant regulations in territories in which they are sold;

OND and ONT operate two Quality Management Systems (ISO 13485‑OND & ISO 9001‑ONT).

The postholder is responsible, alongside and as directed by the Head of QA, for leading and supporting the quality team, its functions and processes. This responsibility extends to the quality‑related activities of staff performing quality functions (e.g. in software release, manufacturing, design etc.).

In addition, the post holder is responsible for ensuring that the QA team is suitably qualified, trained and experienced to undertake their duties competently – in this regard this role will be responsible for overseeing and directing development and training of the QA team and wider QA stakeholders in the firm.

The post holder shall have the authority to review and approve all processes, documents and records.

Duties include, but are not limited to:

• Performing the role of management representative for both ISO 9001 and ISO 13485 systems (as delegated by the Head of QA) and performing aspects of the Person Responsible for Regulatory Compliance (PRRC) per the EU IVDR (as delegated by the Head of QA).
• Acting as support and most senior deputy to the Head of QA, representing the Head of QA (as directed) in any matter.
• Ensure the development, implementation and maintenance of ONT’s Quality Management System in compliance with the ISO 9001 standard.
• Ensure the development, implementation and maintenance of OND’s Quality Management System in compliance with the ISO 13485 standard for IVD Medical Devices.
• Accordingly, ensure that the development and competence of the QA team (and wider QA stakeholders) is maintained to an appropriate level.
• Oversee and manage the development and maintenance of the ONT and OND quality systems to support the strategic, and day to day needs of the businesses.
• Co‑ordinate the quality business processes in ONT and OND to maximise efficiency, particularly areas in common for the development, manufacture and distribution.
• Perform and/or manage the processing and approval of Change Control, CAPA, Batch release and support post market surveillance as appropriate.
• Perform and/or manage internal audits. Support and manage audits from external 3rd parties as required. Support supplier audit program as required.
• Identify opportunities for the development and promulgation of quality awareness and quality concept/skills competence within the QA team and with quality stakeholders across the firm.
• Work with the regulatory affairs organisation to support new product introduction, regulatory filings and post market surveillance activities.

Any other reasonable duties as required.

Qualifications /

Education:

Qualification to BSc level or higher in relevant engineering (electronics or software) or scientific subject area.

Qualified lead auditor.

Experience: A minimum of 10 years’ experience managing a full lifecycle quality management team in the IVD industry. This is a key requirement and is not negotiable. Experience of managing quality assurance compliance of IVD products against the IVDR while supporting RUO product lines is a must. Experience with and leading to…