Head of Dia RDT for Quality & Regulatory Science

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.

Roche Digital Technology (RDT) is where innovation meets purpose. As a global team at the heart of Roche, we are a community of business-minded technologists committed to help shape tomorrow's digital future of healthcare. Our mission is to power Roche through cutting-edge digital technologies, harnessing the potential of artificial intelligence, data, and scalable tech innovations. Driven by purpose and passion, we're building a future where digital is a core strength across all of Roche, enabling smarter ways of working, unlocking human potential, and driving breakthroughs that truly matter for millions of patients around the world.

As the Head of Compliance, Quality, Regulatory, and Portfolio Planning, you will be a critical executive within the Roche Digital Technology (RDT) organization. You serve as the strategic leader accountable for driving the performance and results of a large and complex department, ensuring our operations not only meet but proactively exceed industry and organizational standards.

Your primary purpose is to secure our license to operate by embedding a culture of integrity and excellence that enables accelerated innovation. This role demands a high-level strategic thinker who contributes to the departmental strategy and applies in-depth industry knowledge to develop plans and deliver measurable results in fast-changing regulatory environments. You will provide leadership to leaders and senior specialists, fostering an environment of transparency and continuous improvement where quality is central to business success.

This leader will drive the development and execute midterm departmental plans, controlling resources and influencing decisions across the function:

• Strategic Compliance and Quality Leadership: You will lead the development and implementation of a robust, future-proof framework for compliance, quality, and regulatory adherence. You proactively ensure that all operations, from product development to delivery, fully meet global industry standards, with a focus on digital-first compliance, data governance, cybersecurity, and emerging AI/ML regulatory standards.

• Regulatory Command and Audit Readiness: You will oversee all regulatory matters and serve as the primary executive point of contact for audits. You ensure the organization is always prepared by maintaining meticulous records and processes that demonstrate full adherence to all governance frameworks.

• Portfolio Planning and Strategic Governance: You will strategically manage the operational portfolio, optimizing resource allocation and ensuring all initiatives are not only compliant and of high quality but also tightly aligned with business and organizational priorities. You control the resources and policy formation across the portfolio lifecycle, from initial planning to completion.

• Culture of Excellence and Accountability: You will foster a culture where compliance and quality are viewed as integral enablers of business success and rapid digital adoption. By building a transparent and collaborative environment, you will motivate teams to take ownership of their responsibilities.

• Business Value Articulation and Influence: You will act as a strategic partner, negotiating with senior management to clearly articulate the business value of rigorous quality and compliance. Your ability to connect regulatory requirements to business outcomes is key to driving change and securing buy-in.

• Talent Stewardship: You will actively develop and mentor the next generation of leaders, identifying high-potential talent, creating clear development pathways, and managing multiple, large, and diverse teams of leaders and/or senior professional staff.

Success in this leadership role requires a sophisticated combination of strategic acumen, regulatory expertise, and proven capacity to shape strategy and manage complex teams.

• Required Education and Experience: Master's Degree required. Minimum of 10 years of deep experience in Quality and Regulatory Science, including hands-on experience with Quality Management Systems (QMS) and e-Signature processes. Experience could come from Manufacturing, Clinical, or Diagnostics settings. (A PhD is highly desirable.)

• Detail-Oriented and Meticulous: Possesses a profound affinity for details and an unwavering drive to follow through on all tasks until they are completed to the highest standard.

• Strategic Regulatory Acumen: A deep and sophisticated understanding of global industry regulations and their practical application within a digital technology and diagnostics context.

• Culture-Building Leadership: The proven ability to inspire and build a culture of accountability and continuous improvement from the ground up.

• Change Management and Influence: Exceptional skills in influencing stakeholders at all levels, articulating complex regulatory and quality requirements in a way that highlights their business value and motivates action.

• Analytical Problem-Solving: The ability to proactively identify potential risks and challenges related to compliance and quality, and to develop comprehensive, long-term solutions leveraging resources within or outside the department.

• Leadership Development & Talent Management: Proven ability to manage multiple large, potentially diverse teams of leaders and/or senior professional staff.

NB: Please note that this is only for the US. The expected salary range for this position based on the primary location of Indianapolis, IN is between $156,200 - $290,200. 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
Relocation benefits are available for this position.

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.

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