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
Who We AreAt 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 PurposeAs an Operations Quality Network / Chapter Technical Lead you are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and the We@Roche Diagnostic Commitments. 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 are a strategic business partner that breaks 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.
This role is specific for Supply Chain Quality. You are accountable as the Technical Lead for Supply Chain Quality Partnerships and at all global site(s) and ensuring compliance with applicable and regional regulatory requirements. You will work closely with Supply Chain, Functional Leaders, the Networks and other Quality & Regulatory teams to develop strategies, set priorities, to ensure achievement of organizational, quality, and departmental goals as well as how best to participate in Squads and Community of Practices.
As Supply Chain Quality Technical Lead, you will be a member of the Supply Chain Quality Chapter within the Operations Quality network. In this position, you will be the leading figure and key point of contact for the Chapter Lead Supply Chain Quality, the respective sub-network-leads and all affiliates to align on all aspects related to handling, storage and distribution (HSD) oversight. The role includes active liaison with the module owner and stakeholders regarding the HSD - module of the mQMS. This role will also focus on near patient product distribution with a heightened focus on Point of Care Prouts.
This role is a member of the Global Operations Quality Extended Leadership Team (GOQexLT).
You will be responsible to:

• Drive business results and customer value
• Perform activities as required to meet Q&R goals and objectives independently and leads 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 product and process understanding and is able to translate this understanding into tangible learnings for other employees.
• Act as a role-model for Agile behaviors. Models behaviors to support transformation to new, more Agile Ways of Working - e.g. new decision making/governance practices, collaboration, etc
• Navigates in complex situations by applying a diverse skill set
• Document authoring and review as required to support changes. 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. Thinks proactively rather than reactively
• Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management
• Leads a community of practice for the Global Dia organization, is a single point of contact or a Global mQMS module lead or liaison

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

• Ability to work day to day without supervision to correctly complete daily scheduled and unscheduled activities. Initiates activities independently and initiates interactions across departments as applicable. Initiates daily activities independently with cost, culture and compliance. Has courage to make decisions even outside of scope/comfort zone. Is decisive and does not procrastinate on decisions; develop solutions and present both issues and solutions to your manager
• Leads large/global cross-functional or cross-chapter projects.
• 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
• Implement overarching strategies to shift the focus from compliance only related product quality activities to proactive quality focused product quality activities. A mindset of creativity and experimentation to enable Operations Quality to be a true trailblazer and support radical simplification as well as continuous improvement

Empower and enable the Network

• Build and maintain strong partnerships with colleagues and business patterns to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships
• 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 the 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
• Break down silos and improve working effectiveness as an ‘integrator’ across the organization as needed; in particular through collaboration with other Networks, Chapters and stakeholders to resolve bottlenecks and dependencies, as well as balance work and strategic priorities
• Build and maintain strong partnerships to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships
• Coordinate with Networks and Chapters to aggregate upcoming Product Quality needs and priorities, to better understand resource demands on the Chapters and Networks and for continuous improvement of production and process controls
• Initiates and / or leads Squads in case of specific requests, topics, or projects coming from the Customer Areas

What else do you have in your toolbox:

• Demonstrate experience and knowledge of Daily Management and Continuous Improvement best practices
• At least five (5) years in the Medical Device / Pharma / Biopharmaceutical industry with three (3) years working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience. Recognised 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
• Knowledge of the European, US, China, and International cGMP regulations and demonstrated ability to adequately interpret quality standards considered an advantage
• Has worked in more than one function within quality management and may have worked outside of Quality Management. Can manage highly complex and/or global projects, or equivalent experience

Locations:You are based in Branchburg, Indianapolis, Tucson, Pleasanton, Santa Clara, Carlsbad.
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 patientsThe expected salary range for this position based on the primary location of New Jersey is $111,700 and $241,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
BenefitsWho 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.
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.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
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.