Fusion - Quality Functional Partner

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We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care.

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Make your application after reading the following skill and qualification requirements for this position.

The Position

SE7 / SE8

Your position

The role of Quality Functional Partner involves leading the Q&R hub, representing the Quality organization in LCTs, collaborating with Network Leads, and fostering proactive quality strategies.

Additionally, the role emphasizes modeling agile behaviors and contributing to Roche's long-term ambitions. This role focuses on strategic initiatives, risk management, and fostering a culture of continuous improvement.

The opportunity

Q&R Hub Lead

• Lead the Q&R hub to achieve alignment on shared priorities, addressing quality issues and compliance gaps by connecting to critical pre- and post-market issues.
• Drive data-based action plans, propose solutions, and provide appropriate support and resolution.
• Communicate critical quality or regulatory issues and risks to ensure transparency and unified messaging.
• Initiate and lead squads for specific requests, topics, or projects from the Lifecycle Team (LCT) or Customer Areas.

For LCT Support

• Represent the Quality organization in all aspects for LCT, partnering to resolve quality issues and ensuring prioritization to meet customer demands.
• Serve as the main point of contact for Quality in LCTs, providing guidance and receiving quality-related requests.
• Collaborate with Quality Function Partners (QFPs) from all Customer Areas to share lessons learned.

Support and Advance the Work of Q&R

• Lead or support strategic initiatives to shift focus from reactive to proactive quality, and foster an agile mindset.
• Build and maintain strong partnerships to ensure alignment on strategic projects and day-to-day activities. Break down silos and improve working effectiveness through collaboration with other Networks, Chapters, and stakeholders.
• Align with design quality assurance to improve product quality at launch. Promote a culture of continuous improvement, driving solutions and decision-making even without perfect solutions.
• Lead and support audit and CAPA activities as applicable. Collaborate closely with Product Quality Leads (PQL) to implement data-driven solutions throughout the organization.
• Collaborate and coordinate with Network Leads on areas of concern to bring action and to provide visibility. Act as role model for Agile behaviors and support the organization’s transformation to new more Agile Ways of Working.

Who You Are

This role requires a bachelor's or master's degree with 7-10 years of experience in quality management or quality control, or a PhD with 5-10 years of experience, along with QP qualification according to AMG 15 Approbation as pharmacist if necessary.

You have over 10 years of experience in quality and regulatory roles within the diagnostics industry. Your expertise includes deep knowledge of international laws and regulations for the development and manufacturing of diagnostic products, such as IVDR, QSReg, ISO 13485, NMPA, and MDSAP.

You are recognized for your thought leadership in quality and regulatory matters and have a strong track record in building and nurturing capabilities in quality and compliance knowledge, regulatory expertise, communication, and stakeholder management.

These additional points complement your profile :

• Proven ability to lead with creativity and high self-awareness.
• Ability to build networks and inspire agile working.
• Skill in prioritizing resources and fostering positive partnerships through effective influencing and conflict management.
• Recognized as an expert in your specialized area with broad knowledge of your own function.
• Experience solving unique problems that impact the organization.
• Senior advisory experience to management and leadership of large / cross-functional teams, projects, or initiatives.

Locations :

You are based in Tucson, Santa Clara, or Pleasanton.

Relocation benefits are available for this position.

The expected salary range for this position based on the primary location of Arizona is $98,900 and $209,000. 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.

Benefits

Who 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 .

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