Quality Manager - Burgess Hill - ref. h40442715
Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.That’s what makes us Roche.
The Quality Manager role is focused on managing and evolving our integrated Quality Management System (QMS) in line with industry standards, Roche's global standards, and business requirements. The position involves collaborating with various levels of the organisation to ensure compliance with ISO certifications, drive continuous improvement, manage audits, and support business growth and customer satisfaction.
The Opportunity- Sustain and enhance the Quality Management System (QMS) in accordance with ISO standards and Roche's modular QMS (MQMS).
- Manage and execute internal, external, supplier, and distributor audits, ensuring nonconformities are addressed and verified.
- Oversee the management of nonconformities, regulatory changes, and process improvements using tools like 'Trackwise' and 'SalesForce'.
- Control and improve processes across operations, ensuring regulatory compliance and effective change control.
- Coordinate and prepare for external audits by ISO Certification Bodies and Roche, ensuring regulatory alignment.
- Develop and deliver quality training and communication programs, including for new and updated standards.
- Lead and support key projects, business initiatives, and management reviews, aligning with the company's quality objectives.
- You have an Accredited Internal Auditor Qualification (e.g LRQA, BSi, Chartered IIA, or equivalent) with solid, established experience in quality management or an internal auditor role.
- You have excellent understanding of ISO standards (9001, 23001, 27001, 14001 and 45001) as well as medical device regulations & requirements.
- You have an understanding of information security, risk management good practice and health, safety and environmental management system requirements.
- Preferred, but not essential, experience of using the Google Workspace suite of tools, as well as the tool ‘Trackwise’.
The role will include travel to Roche and supplier sites within the UK and Ireland and occasional international travel.
We look forward to receiving your application.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Our UK Diagnostics business, headquartered in Burgess Hill, West Sussex, employs approximately 560 highly skilled individuals. We provide the industry's broadest range of diagnostics and monitoring products & services, spanning all sectors of the market: from small hand held devices used directly by patients or healthcare professionals, to large diagnostic instruments found in hospital laboratories.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd.At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age.
We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.