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
ROLE PURPOSE:
The role of the Quality & Process Partner is to support Clinical Operations (CO) strategic directives by ensuring the proactive development and management of optimal business processes that enable compliance and highest quality standards are met. The postholder will collaborate with stakeholders within Research and Early Development (pRED) and across the enterprise, as well as represent CO in the respective areas of Process Management as well as Quality and Compliance as it relates to GCP/GVP.
As a Quality & Process Partner in our Research and Early Development (pRED) Clinical Operations department you will primarily responsible for
* Providing strategic oversight and direction on how best to address all quality issues arising from pRED studies (via audits or otherwise) and ensures action plans are created and implemented to address findings. Ensures learning from audits are consistently shared within all applicable areas of pRED Clinical Operations and DTAs
* Functioning as the content expert for Quality & Processes across all relevant pRED Clinical Operations and DTAs groups, this includes the proactive identification of risks and proposal for risk mitigation strategies. Providing the required support during HA inspections and internal audits, including leading CAPA related activities.
* Developing and executing continuous improvements as they relate to processes and audit/inspection findings
* Developing and maintaining metrics in the relevant ares (eg quality and productivity measures)
* Ensuring pRED Quality Management System (QMS) activities are aligned with global GCP/GVP QMS
* Staying abreast of internal and external developments, trends, and other dynamics relevant to the work of Clinical Operations
* Collaboratng with colleagues across chapters and the Roche Enterprise to ensure fit for purpose processes
HOW YOU WILL DO IT
In Clinical Operations Mindset and behaviour is as important to us as skills and capabilities
Systems thinking
* Connect with the bigger picture, prioritize Roche, pRED or wider team over Function and individual, apply enterprise view
* Collaborative and creative mindset, ability to partner inside and outside Roche
* The statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of the people assigned to this job.
* Show and embrace agile behavior
* Follow a logic of incrementally improving approaches and solutions (80/20 approach where applicable/ MVPs/ iterate)
* Stand in the shoes of stakeholders and able to build strong customer relationships
* Ability to cope with uncertainty and manage ambiguity
* Empowerment and accountability
* Take ownership and accountability
* Empower people to contribute according to their skills, capacity and interest
* Decisions are made by the most appropriate person on the topic
* Foster a speak-up culture
* Demonstrate a growth mindset
* Give, seek and receive constructive feedback
* Openly and proactively share information, failure, ideas, experience and learnings with others
* Drive innovations and foster the power of experimentation
* Create value in an agile organization by increasing our focus on playing the role of Visionary, Architect, Coach and Catalyst
* As a visionary, you facilitate the creation of a bold, shared vision and higher purpose that is co-create with customers to advance a vision.
* As an Architect, you seek value creation across the whole organisation, shaping organisational architecture and culture.
* As a Coach you help everyone in the network build the skills and mindsets they need to succeed in an empowered system, acting as a role model and coach, with a willingness to be coached.
* As a Catalyst you help connect others' work to a collective purpose, creating connections and collaboration across the organisation.
WHO YOU ARE:
You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, patient centric and entrepreneurial spirit.
* Have a growth mindset and are excited about learning through experience
* Feel comfortable thinking on your feet and thrive in fast paced, ambiguous and highly collaborative environments
* Have extensive years of experience in pharmaceutical and/or healthcare industry and drug development experience (therapeutic area experience a plus)
* Demonstrates the ability proactively, Quality and Process solutions with the ability to manage emergent compliance risks.
* Hold a university degree or equivalent years of experience, preferred focus in life sciences
* Find passion in achieving successful outcomes by leading, coaching and inspiring others
* Want to make a difference and find excitement in innovating practices, therapeutics and processes
* Possess strong working knowledge of drug development process and respective regulations
* Feel comfortable traveling internationally based on specific program needs
* Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
* Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
* Strong project management and process improvement skills. Sound knowledge working with operational excellence methodologies and tools, such as value stream mapping, business process redesign, Six Sigma, LEAN, modeling and simulation, cycle time reduction, etc.
* Experience with risk management tools and processes within the clinical quality framework.
* The statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills
* required of the people assigned to this job.
* Able to act urgently for health authority inspection matters and are experienced with delivering effective CAPA management solutions.
* Ability to analyse, interpret and solve complex problems.
* Ability to think objectively and with creativity and innovation
YOUR LOCATION:
Welwyn, or Basel
pRED CLINICAL OPERATIONS:
Our North Star is to increase R&D Productivity and Patient Centricity. This is supported by our CO Strategy to deliver value for pRED CO, pRED BHAGs and our portfolio. We aspire to be a leading edge Clinical Operations organisation that drives innovative patient-centric approaches in study design and execution, utilizes advanced analytics to drive data-driven decisions, and embeds innovative technologies into our ways of working to improve productivity delivery of programs and studies. We strive to create a workplace where team members own their own development and learning and are empowered to create and innovate.
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Welwyn. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
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.