LTO Quality Assurance Expert (12 month temporary position)

2703 Roche Products Limited; Welwyn Hatfield; On-site; GBP 65,000 - 90,000; Full time

Job summary

Roche UK is seeking an experienced professional to manage the operational aspects of the Pharmaceutical Quality Management System and to support the Qualified Persons in fulfilling regulatory obligations.

You will translate global GxP standards into Roche policies, drive efficiency while maintaining rigorous compliance, and collaborate with a cross functional team to sustain Roche UK’s Licence to Operate and protect patient safety.

Qualifications

• Working in a GxP Quality Assurance role providing quality and compliance expertise in support of Unplanned and Planned Events, CAPA management, Document management, and Quality Risk Management
• Commercial and/or Clinical Batch Record review for product release
• Health Authority Inspections

Responsibilities

• Operational management of all key Pharmaceutical Quality Management System (QMS) processes and supporting the Qualified Persons
• Translate external and global GxP requirements into Roche policies & procedures
• Adapt to change and identify opportunities while maintaining a laser focus on ensuring compliance; playing a key role in retaining Roche UK’s Licence to Operate
• Utilise skills to work exibly as part of an empowered, self-managed, multi-skilled team to deliver foundational and Squad-prioritised work
• Be authentic and self-accountable, a creative problem solver, a critical thinker and cultivate collaborative relationships across the organisation

Skills

GxP Quality Assurance

CAPA management

Document management

Quality Risk Management

Education

Bachelor Degree in Science

Job description

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 Position At Roche we are here to deliver better outcomes to more patients, faster. Our achievements help to transform the lives of millions of people. We’ve been supporting patients for over 100 years in the UK, building a reputation that we’re intensely proud of. Through this success, we’ve set an incredibly high standard. Those expectations continue to grow. The environment in which we operate changes at an ever-increasing pace. The industry is never going to stand still. As one united team at Roche UK, we know we need to boldly respond to these changes whilst keeping our customers and our patients at the heart of everything we do. So, we’re shooting for the stars, transforming ourselves into a much more open, dynamic, transparent, inclusive, collaborative and agile business.

Purpose

• You will be responsible for the operational management of all key Pharmaceutical Quality Management System (QMS) processes and supporting the Qualified Persons in fulfiling their company and legal obligations.
• You will be responsible for maximising the potential of the pharmaceutical business by ensuring external and global GxP Quality requirements are translated simply into Roche policies & procedures.
• You will need to be adaptable to change and entrepreneurial in nature in order to identify opportunities, while maintaining a laser focus on ensuring compliance; therefore playing a key role in retaining Roche UK’s Licence to Operate.
• You will utilise skills and capabilities to work exibly as part of an empowered, self-managed, multi-skilled team to ensure Foundational and Squad-prioritised work is delivered in line with Organisational principles.
• You need to be authentic and self-accountable, a creative problem solver, a critical thinker and able to cultivate collaborative relationships across the organisation.

Career Opportunities

• You will use broad and comprehensive expertise within the GxP Quality environment to lead “Foundation work” and partner with the business to solve complex quality issues that impact the Chapter and/or wider business.
• You will complete "Foundational work" with continual review of ‘how’ it is done to drive efciency and minimise resources required to do it (without compromising on necessary standards).
• You will act as a guardian for high standards of compliance, ethics and safety; putting patients at the centre of all actions by consistent business behaviour that complies with applicable laws, industry codes and Roche’s Code of Conduct.
• You will collaborate with internal and external parties to anticipate trends and impact to QMS, mitigate GxP compliance risks, address gaps and enable the resolution of unique or unprecedented issues.
• You will own your development to ensure continuous skills and capabilities growth in line with your passion and the needs of the Organisation (present and future).

Qualications and Experience

• Bachelor Degree in Science
• Experience of:
  • Working in a GxP Quality Assurance role providing quality and compliance expertise in support of Unplanned and Planned Events, CAPA management, Document management, and Quality Risk Management
  • Commercial and/or Clinical Batch Record review for product release
  • Health Authority Inspections
• Desirable Experience of:
  • Customer Complaints processing and management system
  • QMS key performance indicators trend analysis and management reporting
  • Internal and Supplier Auditing

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. Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche’s largest sites.

Besides extensive development and training opportunities, we offer exible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events. We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Roche is an Equal Opportunity Employer.

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.

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.