Manufacturing Quality Manager

Job Description

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).

As a part of the firm’s expansion of the quality function, it now wishes to create a subteam of QA and QC staff, focusing only on the firm’s 4 production sites (at Abingdon and Harwell). This role will manage the QA function (2 heads) and the QC function (comprising one Lead and 2 heads) reporting to this role. Consequently, reporting to and directed by the Snr Dir of QA, this role will be responsible for overall quality management support of all Production/Operations matters including: resource, facilities, environmental, process control & validation, material specification through to inspection/stocking, production process, internal audit, management of external audit, production of materials/reports (and development of KPIs) for Management Review, non-conformance, process data capture and analysis and CAPA. Change control and Certificate of Conformance activities will be shared with the rest of the Quality team.

Reporting and providing primary support to the Snr Director of QA, the role of the Manufacturing Quality Manager 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, as directed by the Snr Dir of QA, for developing deep relationships with the production functions and for consequently helping evolve a functional and enmeshed quality culture across the production sites.
• The post holder shall have the authority to review and approve all processes, documents and records related to production.
• Acting as local manager of all QA and QC functions and activities across all UK direct (not subcontract) manufacturing sites, providing support and acting as senior deputy to the Snr Dir of QA, representing them (as directed) in any matter within Production.
• All activities required to help ensure the Production QA & QC team to achieve their annual objectives and maintain/sustain the ISO 9001 & 13485 accreditation.
• Establish strong working relationships across the manufacturing teams.
• To support (and as required lead) all internal and external audits (customer, regulatory, certification etc.).
  
  
  

Qualifications/Education

Essential

• Qualification to HND level or higher in relevant science or engineering (e.g. electronics or mechanical) area.
• Qualified lead auditor - desirable.
  
  
  

Experience

Essential

• A minimum of 10 years’ experience managing a production quality team covering both electronics and cleanroom processes, in either an ISO 9001, 13485 or equivalent environment (medical device, aerospace, defence, pharma or automotive).
• Experience with quality assurance management with a majority of the following: PCB manufacture, loom/wiring manufacture, QC (of metalwork, labelling, PCBAs, subassemblies and chemical supplies), “wet processes”, injection moulding and overmoulding and robotic (computer controlled) production processes.
• 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 of monitoring performance and driving change across the QMS through the regular analysis of data.
  
  
  

Desirable

• Experience of the IVD devices industry is advantageous but not necessary, strong understanding of quality principles and demonstrable ability of putting them into practise in a complex manufacturing environment is what is needed.
• Experience of leading (from the manufacturer side) CE audits, FDA inspections is useful but not necessary.
• Deep understanding of process validation, control and traceability of records and materials is strongly desired.
• Experience with wafer chip manufacturing is useful but not necessary.
• Understanding of process risk management (PFMEA) is desirable.
  
  
  

Knowledge/Skills/Abilities/Behaviours

• Detailed working knowledge of an ISOxxxx production standard (e.g. 9001 or 13485) is 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.
• 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/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.
  
  
  

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.