Senior Quality Excellence Lead

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

In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled 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 experienced Quality Lead(s) to join our Quality Excellence Digital team and bring a diversity of thinking and technical experience in various Quality and Digital disciplines e.g GCP, GVP, Data Analytics & Visualisation, Statistical analysis and Artificial Intelligence (AI)

Your Profile & Key Responsibilities

• You are a highly motivated and committed professional with experience and technical knowledge in some of the following areas:

+ Statistical analytics and visualisation
+ Machine learning
+ Relational Databases
+ Working with large and heterogeneous data sets from different sources
+ Programming experience (Python and/or R expertise)
+ Digital technologies such as Generative AI

• You have knowledge and experience of any of the following Clinical Quality areas: GCP, MDR and SaMDs, GVP, RBQM, Risk Management, QMS



• You have demonstrated experience in leading large projects within a matrix environment, whilst facilitating decision making and communications, with strong digital and data literacy.


• You have proven critical thinking and problem solving skills (curiosity, creativity and adaptability), with solid relationship management and influence. You ask challenging questions and are comfortable in difficult conversations.



• You're comfortable in the design and implementation of analytics strategies to enable PDQ outcomes, efficiencies and productivity gains for PDQ


• Participate in Quality Assurance Risk assessments and Audits as an analytics SME and contribute to the effective identification of the right areas of risk and generation of Quality evidence.


• Lead /contribute to the development of methodologies for the use of data analytics or digital solutions and maintain related tools/procedures.


• Lead the operationalisation of data analytics packages or digital solutions in close collaboration with Informatics .


The Product Development Quality organization defines success for these roles through the following key competencies:

• Critical thinking


• Growth mindset


• Communication


• Data-driven decision making


• Problem-Solving (curiosity, creativity and adaptability)


• A proactive risk-based approach and enterprise-wide mindset


• An innovative approach


• Stakeholder engagement and management


• Influencing and negotiation


• Inclusive leadership, coaching and mentoring


• Strategic decision making (focus on the work that adds value)


• Maximizing and enabling results with velocity


• Self-starter driving impactful business outcomes


Your Application

Please provide your current compelling CV & Cover Letter. The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process. We are accepting applications until 28.09.2024

The role will be based at our Welwyn or Mississauga sites. Please note that we are not able to provide any relocation benefits.

Some travel may be required to support the role.

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 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.


• You are a highly motivated and committed professional with experience and technical knowledge in some of the following areas:

+ Statistical analytics and visualisation
+ Machine learning
+ Relational Databases
+ Working with large and heterogeneous data sets from different sources
+ Programming experience (Python and/or R expertise)
+ Digital technologies such as Generative AI

• You have knowledge and experience of any of the following Clinical Quality areas: GCP, MDR and SaMDs, GVP, RBQM, Risk Management, QMS



• You have demonstrated experience in leading large projects within a matrix environment, whilst facilitating decision making and communications, with strong digital and data literacy.


• You have proven critical thinking and problem solving skills (curiosity, creativity and adaptability), with solid relationship management and influence. You ask challenging questions and are comfortable in difficult conversations.



• You're comfortable in the design and implementation of analytics strategies to enable PDQ outcomes, efficiencies and productivity gains for PDQ


• Participate in Quality Assurance Risk assessments and Audits as an analytics SME and contribute to the effective identification of the right areas of risk and generation of Quality evidence.


• Lead /contribute to the development of methodologies for the use of data analytics or digital solutions and maintain related tools/procedures.


• Lead the operationalisation of data analytics packages or digital solutions in close collaboration with Informatics .


The Product Development Quality organization defines success for these roles through the following key competencies:

• Critical thinking


• Growth mindset


• Communication


• Data-driven decision making


• Problem-Solving (curiosity, creativity and adaptability)


• A proactive risk-based approach and enterprise-wide mindset


• An innovative approach


• Stakeholder engagement and management


• Influencing and negotiation


• Inclusive leadership, coaching and mentoring


• Strategic decision making (focus on the work that adds value)


• Maximizing and enabling results with velocity


• Self-starter driving impactful business outcomes
  
  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., 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 aaa
Roche 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 aabl
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