Quality Partner

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 a Digital QMS Quality Partner 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 enhance established processes, 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.

You will be responsible to

• Drive business results and customer value
• Responsible for performing activities as required to meet Q&R goals and objectives with minimal collaboration with your manager. Able to identify improvements and implement with collaboration. Navigates in situations by applying a diverse skill set with minimal guidance.
• With in-depth specialist knowledge of own job discipline and broad knowledge of related disciplines in the field.
• Document authoring and review as required to support changes. Performs technical reviews, as applicable. May require collaboration with your manager on technically complex technical reviews.
• Can coach and train quality professionals with less experience and provide guidance.
• Preparing documentation for audits as applicable.
• Completing all required training in learning solutions.
• Responsible for training, coaching and mentoring other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met.
• Identifying and escalating issues as they arise and able to provide adequate solutions.
• 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

• Works day to day with minimal supervision to correctly complete daily scheduled and unscheduled activities. Initiates daily activities independently with limited guidance. Has courage to make decisions within scope of responsibility. Is decisive and does not procrastinate on decisions; develops solutions and presents both issues and solutions to the manager.
• Initiate, facilitate, participate and implement process improvements to meet business needs. Able to link responsibilities with both site and Global Quality and Regulatory. Drive innovation within their own area of influence.
• Contribute by participating in large/global cross-functional or cross-chapter squads where it may take a leading role.

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 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, with minimal collaboration from your manager. 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 and leverages these connections to achieve our key results. Identify personal goals and actively manages her or his career to pursue personal goals and priorities with collaboration from your manager.

What else do you have in your toolbox:

• 2 years experience

• 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.

Additional details regarding this role: The Quality Partner will be primarily responsible for supporting the following core activities:

Supporting Global QMS Governance and Strategy, including

• process excellence and change management (for global QMS and network process changes),

• notified body and certification management, and

• Quality Manual maintenance

Supporting Audit and Inspection Management, including

• inspection readiness for health authority and notified body inspections/audits, planning and coordination with internal stakeholder teams

• audit/inspection backroom support

Coordinate Management Reviews, including administration of proactive quality system reviews, quality planning, quality objective setting, and management of quality metrics.

Own Nonconformance and CAPA Management, including program monitoring, partnering and approvals, root cause analysis, and tracking/analytics/visualization of NC and CAPA metrics.

Quality review and approval of QMS procedures and documentation related to management of the QMS.

Quality Agreement Management and Pharma Collaboration.

Collaboration with global teams responsible for supplier management, training, internal auditing, post-market, and information security and privacy.

The expected salary range for this position based on the primary location of California is $72,100-133,900. 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.

Relocation benefits are available for this posting.

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.

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 connection with the on-line application process, please email us at.