Quality Functional Partner

F. Hoffmann-La Roche AG; Indianapolis (IN); Hybrid; USD 104,000 - 222,000; Full time

Job summary

Roche is seeking a Quality Functional Partner in Indiana to lead the Q&R hub, represent Quality in Lifecycle Teams, and drive proactive quality strategies. You will collaborate with network leads and PQLs to resolve quality issues and ensure alignment with regulatory standards.

You will apply data-driven methods, promote agile ways of working, and lead cross‑functional initiatives to raise product quality at launch and beyond.

Qualifications

• Bachelor's or Master's degree with 7–10 years in quality or regulatory roles.
• PhD with 5–10 years also acceptable.
• Deep knowledge of IVDR, QSReg, ISO 13485, MDSAP, and related regulations.

Responsibilities

• Lead the Q&R hub and represent Quality in Lifecycle Teams.
• Drive data-based action plans and risk-based decisions.
• Foster agile mindset and proactive quality improvements.
• Collaborate with PQLs, QFPs, and network leads on key initiatives.

Skills

Quality Management

Regulatory Knowledge

Stakeholder Management

Agile Mindset

Data-driven

Education

Bachelor's degree

Master's degree

PhD

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The role of Quality Functional Partner, involves leading the Q&R hub, representing the Quality organization in Lifecycle Teams (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

You have a Bachelors or Masters degree with 7-10 years of experience in quality management, quality control, or a related business function, or a PhD with 5-10 years of experience. 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.

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

Locations: You are based in Indianapolis, Branchburg, Pleasanton, Santa Clara, Carlsbad, or Tucson. This is a hybrid/on-site role. Remote work arrangements are not available. *Relocation benefits are not available for this position.

Salary

The expected salary range for this position based on the primary location of Indiana is $103,900 and $221,800. 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.

Benefits

Benefits Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together.

Roche is an equal opportunity employer.

It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence.

The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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.

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 rigor, 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. We are Roche.