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 rigour, 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.
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.
The role of the Quality & Process Partner is to support Clinical Operations 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 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.
WHAT YOU WILL DO:
Provides 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
Functions 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.
Develop and execute continuous improvements as they relate to processes and audit/inspection findings
Develops and maintains metrics in the relevant ares (eg quality and productivity measures)
Ensures pRED Quality Management System (QMS) activities are aligned with global GCP/GVP QMS
Stays abreast of internal and external developments, trends, and other dynamics relevant to the work of Clinical Operations
Collaborate 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
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
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-created 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.
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
Basel (Switzerland), Little Falls (US), Welwyn (UK). For administrative purposes only, the primary location is listed as Basel.
Please apply until 29 August 2021.
Roche embraces diversity and equal opportunity in a serious way. We are committed to building teams that represent a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. If you still have questions then please check our FAQs and videos on careers.roche.ch/faq