A pioneering biotechnology company develops, manufactures, and sells products based on its proprietary and market-leading nanopore-based next generation gene-sequencing (NGS) technology. In addition to offering its technologies for research use only (RUO) applications, the company also provides in vitro diagnostic (IVD) instruments utilizing the same complex and innovative NGS platform. It also develops its own assays and reagents and collaborates directly with a broad range of third parties to support assay development.
With design and manufacturing based in Oxford and products marketed globally (across both RUO and IVD sectors), the company ensures that all instruments and assays comply with regulatory requirements in the territories in which they are sold. As part of this compliance, the company operates two Quality Management Systems (ISO 13485 & ISO 9001).
As part of the expansion of its quality function, the company is establishing a dedicated subteam of QA and QC professionals to support its four production sites located in Abingdon and Harwell. This role will lead the QA function (2 direct reports) and the QC function (1 lead and 2 direct reports), reporting to the Senior Director of QA. The position is responsible for overseeing all aspects of quality management across production and operations, including resources, facilities, environmental and process control, validation, material specification, inspection/stocking, production process oversight, internal and external audits, data analysis, CAPA, and development of management review materials and KPIs. Certain responsibilities, including change control and certificates of conformance, will be shared with the broader quality team.
Working closely with and reporting to the Senior Director of QA, the Manufacturing Quality Manager ensures compliance with quality obligations and supports the effective execution of the QMS and the company's broader quality strategy.
Key Responsibilities
- Develop strong relationships with production teams to foster a proactive and integrated quality culture across manufacturing sites.
- Review and approve all processes, documents, and records related to production.
- Act as the local manager for all QA and QC activities across the company's UK manufacturing sites (excluding subcontractors), and as the senior deputy to the Senior Director of QA in production-related matters.
- Lead the Production QA & QC team to achieve annual objectives and maintain ISO 9001 and ISO 13485 certifications.
- Build strong cross-functional working relationships with manufacturing and operations teams.
- Support or lead internal and external audits (e.g., customer, regulatory, certification).
Qualifications / Education
Essential:
- HND or higher qualification in a relevant scientific or engineering discipline (e.g., electronics or mechanical engineering).
- Desirable:
- Qualified lead auditor.
Experience
Essential:
- Minimum 10 years of experience managing a production quality team in electronics and cleanroom environments within an ISO 9001, ISO 13485, or equivalent regulated setting (e.g., medical device, aerospace, defence, pharma, or automotive).
- Experience managing QA/QC across a range of processes, including PCB manufacture, wiring/loom production, inspection of components (metalwork, labelling, PCBAs, subassemblies, chemicals), wet processes, injection moulding, overmoulding, and robotic production.
- Deep understanding of and experience with electronic and software-based products, software as a medical device (SaMD), chemical reagents, packaging, manufacturing, labelling, D&D, risk and change management.
- Demonstrated leadership of teams of 5 or more.
- Proven track record of using data to monitor performance and drive improvements across the QMS.
Desirable:
- Experience in the IVD device industry is beneficial but not essential; a solid understanding of quality principles and their application in complex manufacturing environments is more critical.
- Prior involvement in CE audits or FDA inspections is an advantage.
- Strong knowledge of process validation, traceability, and materials records control.
- Experience with wafer chip manufacturing is helpful but not required.
- Familiarity with process risk management (e.g., PFMEA).
- Knowledge / Skills / Abilities / Behaviours
- In-depth knowledge of ISO-based quality standards (e.g., ISO 9001 or ISO 13485).
- Experience working with external partners and stakeholders, showing discretion and the ability to balance risk and commercial considerations.
- Strong interpersonal and organizational skills, with the ability to influence and lead across functions and seniority levels.
- Ability to build and maintain positive relationships internally and externally.
Attitude / Other Requirements
- Adaptable and proactive mindset, with experience in fast-paced and agile environments.
- Goal-driven with the initiative to develop and evolve effective solutions.
- Strong communication skills, including the ability to explain technical concepts to non-expert audiences.
- Excellent command of written and spoken English.
- High attention to detail and strong prioritization based on risk.
