[ref. c013121] Quality Lead - Roche
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.
In Product Development Quality (PDQ) we take an innovative approach to strive for confidence in the integrity of our data and our processes, agility, and unrivalled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes.
We are looking for a Quality Lead to join our R&D Quality (Product Development Quality) team!
We are recruiting for a role in Quality Assurance Affiliate Teams.
The Opportunity
The Quality Assurance Affiliate teams actively lead or contribute in activities to assess Quality Assurance status, such as audits with focus on GVP, and evaluation of actions taken, preparation and presentation of Quality Brief conclusions (contextualised quality evidence), to business stakeholders and Pharma representatives and ensure appropriate action plans have been developed and determine acceptability of evidence of compliance.
In addition,these teams provide leadership for worldwide Health Authority inspections, including inspection preparation and inspection management activities.
Who you are- You are an experienced quality professional and/or drug safety/pharmacovigilance professional with a strong understanding of risk-based critical thinking.
- You bring innovation, strategic data-driven decision making and good project management skills to your day to day work.
- You are a highly motivated and committed professional with strong experience and technical knowledge in any of the following areas: GVP ideally with paired withRisk Management, QMS
- You have experience in conducting GXP audits and a proven track record in Health Authority inspection leadership, including inspection readiness and inspection management activities.
- You can comfortably lead discussions and decisions related to clinical and/or pharmacovigilance risk with Senior Management and Peer groups, actively contributing to a Culture of Quality.
Ad hoc travel is required to support regulatory inspections.
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 Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none.Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.
Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day.At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance.
Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. 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.
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.