Quality Excellence Lead

F. Hoffmann-La Roche AG; Welwyn; On-site; GBP 90,000 - 130,000; Full time

Job summary

Roche is seeking a Quality Excellence Lead to shape and elevate our global quality ecosystem within the Quality Excellence Infrastructure team. You will optimize systems, streamline processes, and provide expert guidance on deviation management and CAPA.

Based in Welwyn, the role requires data-driven quality leadership, RCA and SMART CAPA mastery, and collaboration across functions to accelerate quality outcomes.

Qualifications

• Proven proficiency in data analysis to drive solutions using modern tools.
• Expert knowledge in RCA, SMART CAPA and related quality systems.
• Experience with regulatory audits and inspections.
• Strong data literacy and AI tool familiarity.
• Ability to lead cross-functional change and stakeholder engagement.

Responsibilities

• Develop and improve infrastructure strategies to enable outcomes and productivity gains.
• Maintain quality data to meet regulatory requirements and derive insights.
• Provide expert guidance on workflow troubleshooting.
• Manage deviations and CAPA planning with impact assessments.
• Collate data and derive actionable insights using dashboards and KPIs.
• Support implementation of innovative Quality tools and technologies.
• Contribute to business methodology using data analytics.
• Support large-scale changes with systems-thinking and cross-business alignment.

Skills

Digital & Data Literacy

Root Cause Analysis

SMART CAPA principles

Regulatory quality knowledge

Audit & Inspection Experience

Change leadership

Stakeholder engagement

Problem-solving

Communication skills

AI tools familiarity

Tools

AI tools

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

At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. As Quality Excellence Lead in our Quality Excellence Infrastructure team, you will help shape and elevate our global quality ecosystem, optimizing systems, streamlining processes, and providing expert advice on deviation and CAPA management.

Key Responsibilities

• Contributes to the development, implementation, maintenance, and improvement of infrastructure strategies to enable outcomes, efficiencies, and productivity gains.
• Maintains Quality data to fulfill regulatory requirements and develops key data insights to catalyze decision making.
• Manage process-related inquiries, providing expert guidance on workflow troubleshooting.
• Manage deviations, oversee CAPA planning and perform thorough impact assessments.
• Collate data and derive actionable insights, leveraging functional dashboards and KPIs to identify systemic risks and emerging compliance trends.
• Resolve complex queries and oversee metric escalation.
• Supports implementation and continuous improvement of innovative Quality tools and technologies.
• Contributes to the development of business methodology including the use of data analytics and maintains related tools/procedures.
• Supports large-scale changes with systems-thinking, strategic collaboration, and alignment across the business to streamline and accelerate quality outcomes.

Who You Are

You are a resilient, data-driven quality professional who excels at bringing clarity and structure to complex, fast-paced environments. To be successful in this role, you bring Digital & Data Literacy: Proven proficiency in analyzing data to drive solutions using modern tools, including strong competency utilizing AI and AI agents Core Quality Expertise: Mastery in Root Cause Analysis (RCA), SMART CAPA principles, and strong technical knowledge in areas like GCP, GVP, MDR, SaMD, QMS, or Risk-Based Quality Management (RBQM). Audit & Inspection Experience: A track record of participating in and facilitating regulatory audits and inspections. Stakeholder Partnership & Change Leadership: Drives cross-functional collaboration and alignment on quality initiatives through effective negotiation, influencing, change management, and resilient stakeholder engagement Problem-Solving & Collaboration: Outstanding critical thinking, decision-making, and communication skills, with a passion for coaching and upskilling colleagues and developing future talent. Independent & Collaborative Delivery: Demonstrated ability to work self-sufficiently to achieve results, while thriving as a reliable, adaptable partner within broader global teams.

The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.

Benefits

• Relocation benefits are not available for this job posting.

Location & Compensation

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Welwyn. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

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.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd.

At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work. 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.