Associate Director, Quality Assurance
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Job Description
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 Associate 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 quality team and the wider quality function.
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.).
The post holder shall have the authority to review and approve all processes, documents and records.
Duties
Duties include, but are not limited to:
• Acting as support and senior deputy to the Head of QA, representing the Head of QA (as directed) in any matter.
• All activities required to help ensure the QA team achieve their annual objectives and maintain/sustain the ISO9001 & 13485 accreditation. This may require the role to fulfill part of the role of "Person with Responsibility for Regulatory Compliance" as per the EU IVDR.
• Establish strong working relationships across the business to facilitate best practices in the risk management, product development, testing, manufacture and post market surveillance of products.
• To support (and as required lead) all internal and external audits (customer, regulatory, certification etc.).
• Any other reasonable duties as required.
Qualifications
Qualification to BSc level or higher in relevant engineering (electronics or software) or scientific subject area or proven experience in working in a relevant quality management role - essential.
Qualified lead auditor (desired).
Experience
Essential:
A minimum of 10 years' experience managing a full lifecycle quality management team in the IVD industry.
Experience with and leading to demonstrable understanding of electronic devices, software devices (which may or may not include SaMD), software assays, chemical reagents, packaging, manufacturing, labelling, design and development, risk management and change management.
Experience of team management and leadership of teams >5.
Experience and consequent deep understanding of design/development (pre-market) activities, production control (in both "single piece flow" and "batch/volume" production environments), and post-market (lifecycle change management) areas.
Experience of monitoring performance and driving change across the QMS through the regular analysis of data.
Specifically this experience should include in-depth work with both complex instrumentation and IVD reagents and assays.
Experience of working in an MDSAP-compliant environment. Experience of leading ISO 13485 certification audits.
Detailed understanding of risk management, process validation, clinical validation and IVD performance evaluation requirements.
Experience of working in an IVD environment along with practical experience in working to applicable management standards (i.e. ISO 13485).
Experience with and demonstrable understanding of some of the following: IEC14971, IEC 62304, IEC 62366, GLP, EMC (IEC61326), IEC61010-1, packaging/transport standards, labelling standards and IVDR performance evaluation requirements
Desirable:
Experience of leading (from the manufacturer side) CE audits certification, surveillance and unannounced audits. 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).
Knowledge/Skills/Abilities
Essential:
Detailed working knowledge of ISO13485, MDSAP requirements 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.
Attitude/Behaviours/Other
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
About Us
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 of DNA and RNA. The technology is used in more than 100 countries to understand the biology of humans and diseases, plants, animals, bacteria, viruses and whole environments.
Oxford Nanopore was founded in 2005 as a spin-out from the University of Oxford and now employs over 1000 employees around the world.