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Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

We are seeking a dedicated professional to sustain and enhance our integrated Quality Management System (QMS) based on our Diagnostics' modular quality management system (MQMS). This role is pivotal in aligning our QMS with company goals, industry standards, Roche standards, and certification and business requirements.

You will lead the Quality Team and will interact with Roche's regional and global teams to understand best practices and develop improvement opportunities for the UK & Ireland, EMEA, and global operations. You will collaborate across all levels of the organization to evolve the QMS, deliver key quality objectives, and drive continuous improvement. Your responsibilities will include controlling and enhancing the quality of operational processes in line with ISO standards (ISO 9001, 23001, 27001, 14001, and 45001), managing effective change control and nonconformity processes, and overseeing internal, external, supplier, and distributor audit programs. Additionally, you will support non-regulatory customer complaint management to ensure customer satisfaction and ongoing improvement.

This role is office based (Burgess Hill) requires travel to Roche and supplier sites within the UK and Ireland, with occasional international travel.

Your Key Responsibilities

• Leadership/line management of 3 Quality Managers and One Graduate (Q&R rotation)

• Member of the Q&R Leadership Team

• Design, develop and sustain a quality management system in line with the company goals, ISO standards and business strategy.

• Contribute to the creation and implementation of best practice Quality vision, strategy, policies, processes and procedures to support the business in delivering an industry-leading experience for our customers and patients.

• Contribute to new business initiatives and projects by reviewing and communicating the impact on the quality management systems.

• Manage a document lifecycle framework to ensure all policies and procedures are updated (DiaDoc), to meet the needs of the organisation and external certification bodies (ISO).

• Delivery of an audit programme across all three sites, suppliers and third party partners.

• Coordinate, prepare and manage external audits by ISO Certification Bodies and Roche.

• Management of nonconformities (NCs) and improvements raised during audits and during day to day business in Trackwise. Follow-up and closure of these actions providing business support where required.

• Management of process changes compliant with regulatory, ISO and company requirements.

• Management of a process for responding to and analysing non regulatory complaints in SalesForce.

• Create, manage and deliver Quality training and communications as required e.g. induction training

• Implement new and updated ISO standards across the business, as and when required.

• Manage the implementation of new and updated Roche Standards and global processes (GSPs) into operational processes.

• Manage and deliver projects as and when required by the organisation.

• Plan, prepare and conduct ISO Management Reviews with the Senior Leadership team.

Your Profile

Qualifications/Experience

• Accredited Internal Auditor Qualification (e.g LRQA, BSi, Chartered IIA, or equivalent).

• Degree educated level or equivalent 5+ years experience in quality management or an internal auditor role.

• Previous Line Management/Leadership experience

• Preferred, but not essential, experience of using the Google Workspace suite of tools.

• Preferred, but not essential, experience of the tool ‘Trackwise’

Knowledge

• Excellent understanding of ISO standards to include: 9001, 23001, 27001, 14001 and 45001

• Understanding of the medical device regulations and requirements

• Understanding of information security, business continuity and risk management good practice.

• Understanding of health, safety and environmental management system requirements and statutory requirements for the UK & Ireland.

Your application

Please upload only your current compelling CV. This role is open in the UK and to be based in the South region of the UK.

We are looking forward to 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.