At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The PositionSummary and Purpose
Sustain an integrated quality management system (QMS) based on the Diagnostics’ modular quality management system (MQMS), aligned with the company goals, required industry standards , Roche standards, certification and business requirements.
Interact with the Roche organisation at a regional and global level to understand best practices and develop opportunities for improvement in the UK & Ireland, EMEA and global.
Responsible for the evolution of the quality management system collaborating with all levels of the organisation to deliver key quality objectives and continuous improvement.
Control and improve the quality of all processes throughout operations in accordance with relevant ISO standards (ISO 9001, 22301, 27001, 14001 and 45001).
Responsible for effective change control and nonconformity management processes with an impact on ISO standards and regulatory requirements.
Manage and deliver the internal, external, supplier and distributor audit programme, to ensure all nonconformities raised during audits are effectively corrected and independently verified.
Support the management of non regulatory customer complaints to deliver customer satisfaction and continuous improvement.
The role will include travel to Roche and supplier sites within the UK and Ireland and occasional international travel.
This role reports directly to the Quality Manager Team Leader.
Knowledge
Excellent understanding of ISO standards to include: 9001, 22301, 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.
Role Summary and Accountabilities
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 the affiliate, warehouse, suppliers, distributors (as required).
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/SAP. 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.
Other key responsibilities
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.
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.
Preferred, but not essential, experience of using:
Google Workspace suite of tools
Trackwise
SAP
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
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.
