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).
Reporting and providing primary support to the Head of QA, the role of the Director Quality Assurance is responsible for ensuring the firm fully complies with its quality obligations, to support the management and execution of the QMS, the management and development and growth of the quality team and the management and effective performance and execution of the wider quality function across the business (focusing on effective and desirable outcomes as well as compliant processes).
Key Responsibilities
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
Duties include, but are not limited to:
1. 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).
2. Acting as support and most senior deputy to the Head of QA, representing the Head of QA (as directed) in any matter.
3. Ensure the development, implementation and maintenance of ONT’s Quality Management System in compliance with the ISO 9001 standard.
4. Ensure the development, implementation and maintenance of OND’s Quality Management System in compliance with the ISO 13485 standard for IVD Medical Devices.
5. Accordingly, ensure that the development and competence of the QA team (and wider QA stakeholders) is maintained to an appropriate level.
6. 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.
7. Co-ordinate the quality business processes in ONT and OND to maximise efficiency, particularly areas in common for the development, manufacture and distribution.
8. Perform and/or manage the processing and approval of Change Control, CAPA, Batch release and support post market surveillance as appropriate
9. Perform and/or manage internal audits. Support and manage audits from external 3rd parties as required. Support supplier audit program as required.
10. 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.
11. Work with the regulatory affairs organisation to support new product introduction, regulatory filings and post market surveillance activities.
Any other reasonable duties as required.
PERSON SPECIFICATION Essential Desirable 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.
Product/technology - Experience with and leading to demonstrable understanding of software assays, chemical assays, chemical reagents and library prep kits, biologics, and microfluidic handling systems (e.g. cartridges) as well as their packaging, manufacturing, labelling, design and development, risk management, process validation and change management is a must.
QMS - Experience of team management and leadership of teams >5. Specifically experience of QA systems management, production QA management, design QA management, supplier and distributor QA management.
Audits - Experience of leading (from the manufacturer side) CE audits certification, surveillance and unnanounced audits.
QMS systems - Experience of implementing (from scratch) and managing (through lifecycle) both electronic QMS and within adjacent electronics systems (e.g. for production, complaints, sales order processing/product realisation, design and development, software development etc.). Experience of and at least a basic understanding of computer systems validation is a must.
QA activities - Experience and consequent deep understanding of design/development (pre-market) activites, production control (in both “single piece flow” and “batch/volume” production environments), and post-market (lifecycle change management) areas.
Experience with and demonstrable understanding of some of the following: GDP, GMP, GMLP, Good Distribution Practice, GAMP5, IEC 14971, IEC 62304, IEC 62366, GLP, packaging/transport standards, labelling standards and IVDR performance evaluation requirements.
Experience of subcontracting large portions of the QMS responsibilities to a second or third party (e.g. manufacturing, complaints handling) is desirable.
Experience with electronic devices, software devices (which may or may not include SaMD) is desirable.
Experience of FDA inspections or leading MDSAP audits is strongly desired.
Experience of management of (and consequent future prevention of) recalls or other challenging health authority interactions is highly desired.
Understanding or experience of computer systems validation is desirable (e.g. GAMP5).
Experience of quality management of field manufacturing (service) activities and experience of software production, configuration and distribution (either by direct or remote/cloud/OTA update) is desirable.
Experience with supporting market entry into new markets (either regional or industry segment) and providing strategic planning/support accordingly is desirable.
Knowledge/Skills/
Abilities
Detailed working knowledge of ISO 13485 and the IVDR are essential.
Demonstrable experience of working with external partners and stakeholders, showing a balanced level of discretion and sensitivity to both risk and commercial interests is strongly desired.
Able to understand how technical standards are applied to aid the development of IVD and general professional products.
Able to distil complex overlapping or interacting regulatory demands (regulations, guidance, standards) down to simple and direct courses of action for colleagues is vital as is providing exemplar solutions to those colleagues and working with them to achieve success.
Excellent interpersonal and organisational skills with ability to influence at a senior level. Able to form and maintain good relationships both internally and externally.
Knowledge of MDSAP requirements is desirable Attitude/Other
Requirements
Positive and flexible attitude and experience of fast paced and agile environments. Must be goal-oriented and able to develop/evolve their own solutions.
Highly effective communicator to non-expert professional groups.
Excellent written and spoken English.
High level of attention to detail as well as an ability to prioritise based on risk.