FUSION - Technical Lead - Risk Enabler

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.

Who We Are

At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - 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.

Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient's right and every employee's responsibility.

Role Purpose

As an Operations Quality, QSE Chapter Technical Lead Risk Management you are a key Operations Quality interface who works to enable partnering with functional groups globally. You help solve challenging and strategic issues that have an impact on global functions, networks and chapters by leading global and functional, overarching initiatives. You are responsible for building and developing your capabilities to contribute more to the team, customers and patients. You apply new approaches to improving your work to increase productivity, reduce costs or mitigate significant compliance issues within your area of influence. You work as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.

Specifically for this position focusing on Risk Management, you:

• Own the Risk Enabler, Risk Assessment GSP and training materials,

• Work with the Module Owners to ensure each process has considered Risk as an input to the design and execution of their process

• Connect risk management throughout the mQMS processes ensuring knowledge gained as an output in one area is an input upstream to the design, development, manufacture, and delivery of Roche products and solutions

• Ensure through our Product Realization that risk management is an enabler to deliver products quickly, efficiently and safely to our patients and customers

• Solve challenging and strategic issues; leading global and functional overarching project teams; anticipating challenges; innovative and conceptual thinking

• Acts as a coach for other functional areas concerning how the Risk Enabler is applied and how to assess risk per our Risk GSP.

• You are a strong and visionary and catalyst leader.

• You are someone who is ready to create an environment of innovation and collaboration. You support the operational activities of the organization by promoting and developing a strong connectivity of risk management with manufacturing and development sites to ensure the organization is cohesively delivering overarching product quality strategies.

You will be responsible to:

• Drive business results and customer value

• Perform activities as required to meet Q&R goals and objectives independently and lead through the performance of these activities. Able to identify improvements and implement independently. Participate in cross functional Global initiatives.

• Responsible for training, coaching, mentoring and leading other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met. Has a deep Risk Process understanding and is able to translate this understanding into tangible learnings for other employees.

• Navigates in complex situations by applying a diverse skill set.

• Document authoring and review as required to support changes. Be point of contact for changes to the Risk Enabler and Risk GSP. Performs technical reviews, as applicable. May require collaboration with supervisor on technically complex technical reviews independently.

• Preparing documentation for, coordinating, leading, and participating in audits as applicable.

• Completing all required training in learning solution.

• Able to troubleshoot issues as they arise, independently develop and implement cost effective and non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance.

• Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.

Advance the work of the Network, making tradeoffs and breaking silos:

• Partner across many global functions on strategic business initiatives incorporating the Risk Enabler into the processes. You act as a catalyst to ensure our mQMS continues to mature and enables the organization to focus on the areas of risk as appropriate.

• Leads and/or participates in large/global cross-functional or cross-chapter projects. Acts as Center of Excellence on both Risk Enabler process and application in product risk processes.

• Develop and Lead process improvements to meet business needs taking into consideration cost, compliance and complexity to implement robust processes. Able to link responsibilities with both site and Global Quality and Regulatory. Drive innovations across the global organization. Provide key thought leadership around use of Risk in the respective process.

Empower and enable the Network:

• Build squads as appropriate across global functions / networks and sites to ensure delivery of the risk enabler.

• Build and maintain strong partnerships with colleagues and business partners to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

• Negotiate with Senior Leadership across the Roche Dia organization to influence decision-making.

• Be the champion and advocate for Engrained Quality at the Site.

• Build a culture of continuous improvement.

Enable the organization's New Ways of Working:

• Act as role-model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in Dia Operating Principles.

• Model behaviors to support the organization's transformation to new, more Agile Ways of Working - e.g. new decision making/governance practices, collaboration, etc.

• Everything you do should contribute directly to the achievement of our Roche Ten Year ambitions, including:

• Double patient access to novel, high-medical-value diagnostics solutions

• Build the leading, profitable insights business

• Improve patients' lives via 'OneRoche Approach' to ecosystem in every country

How:

• Know and follow the Dia Operating Principles and Roche Core Competencies.

• Adopts and adheres to the Leadership Commitments.

• Accountable for meeting commitments. Is flexible, able to shift priorities while balancing commitments and daily work requirements, independently.

• Seeks candid feedback on his or her performance and acts on it.

• Recognizes the contributions of teammates and peers.

• Establishes strong collaborative relationships inter-departmentally, across sites and across all of the global organizations and leverages these connections to achieve our key results. Identifies personal goals and actively manages her or his career to pursue personal goals and priorities independently.

What else do you have in your toolbox:

• 5-10 Years experience; Recognized internally as an expert in own job discipline.

• Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience. Completed training as a technician or laboratory technician; or equivalent qualification for the tasks; limited working experience.

• Can manage highly complex and/or global projects, or equivalent experience.

Locations:

You are based in Tucson, Branchburg, Indianapolis, Pleasanton, Santa Clara, Mannheim, Penzberg, Rotkreuz.

At the Company's discretion, an exception to the location requirement could be made under extraordinary circumstances.

*Relocation benefits are not available for this position.

As this position is part of a global organization, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

Roche is an equal opportunity employer.

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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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