Associate Quality Lead

F. Hoffmann-La Roche AG; Welwyn; On-site; GBP 60,000 - 100,000; Full time

Job summary

Roche in Welwyn is seeking an Associate Quality Lead within PDQ to advance quality strategies across global regulatory standards. You will work with cross-functional teams, use data analytics and digital tools, and help deliver life-changing medicines securely.

A scientific or quality degree is required, with GxP experience. Strong English, independent work, and collaboration will drive audits, data insights, and continuous improvement in a fast-paced healthcare environment.

Qualifications

• Bachelor’s degree in a scientific or quality discipline.
• Experience with GxP regulations (GCP, GVP, MDR) and pharma/biotech environment.
• Strong data literacy and ability to translate data into quality insights.
• Independent, proactive, and well organized.

Responsibilities

• Implement and track risk-based quality management strategies in PDQ.
• Deliver QA activities to assure end-to-end system quality.
• Enhance data collection, perform ad-hoc analyses, provide insights.
• Support compliance initiatives and drive continuous improvement.
• Utilise AI and tools to assist audits and inspection support.

Skills

Data literacy

Project ownership

GxP knowledge

English proficiency

Quality mindset

Education

Bachelor’s degree in a scientific or quality-related discipline

Job description

The Position

The Opportunity Are you ready to shape the future of quality management in healthcare? As an Associate Quality Lead within our Pharma Development Quality (PDQ) function, you will play a vital role in supporting the delivery of quality-focused strategies that reinforce trust in our Quality Management System (QMS). Working with a high degree of independence, you will collaborate with cross-functional teams to ensure our clinical and safety data meets rigorous global regulatory standards. In this dynamic position, you will have the unique opportunity to champion a culture of continuous improvement and innovation. By leveraging data analytics and digital tools, you will help optimise data collection and provide key insights that directly support our mission of delivering life-changing medicines to patients faster and more securely.

Key Responsibilities

• Implement Quality Strategies: Support the execution and tracking of risk-based quality management strategies across the PDQ portfolio.
• Deliver Quality Assurance: Execute targeted activities to assess quality assurance status and generate confidence in our end-to-end systems.
• Manage Quality Data: Enhance data collection procedures, perform ad-hoc analyses, and deliver high-quality data insights to fulfil external regulatory needs.
• Drive Compliance Projects: Participate in departmental or cross-functional compliance initiatives aimed at optimising daily operations.
• Champion Innovation: Drive the adoption of innovative digital tools and technologies into daily workflows to foster a proactive quality culture.
• Foster Collaboration: Build and maintain an inclusive, supportive work environment while executing departmental goals and initiatives under limited supervision.
• Audit Execution: Utilise AI and automated tools to execute audits and synthesize audit evidence.
• Inspection Support: Provide logistical and compliance support for GCP inspections, including scribe duties and back-room document QC.

Who You Are

You are a proactive, organised professional looking to elevate your career in quality management within a global, life-changing industry. You thrive in environments that value continuous learning, offer room for professional growth, and empower you to work independently to make a genuine impact on patient outcomes.

To be successful in this role, you bring:

• A Bachelor’s degree in a scientific or quality-related discipline, or an equivalent combination of education and experience.
• Experience within the pharmaceutical, biotech, or medical device industry, with a foundational understanding of product development and GxP regulations (e.g., GCP, GVP, MDR).
• Strong digital and data literacy, with the ability to interpret data and translate it into actionable quality insights.
• Exceptional organisational and execution skills, alongside a demonstrated ability to take ownership of projects proactively.
• Developing expertise in Critical to Quality (CtQ) factors and functional group operations.
• Fluency in written and spoken English, with strong presentation skills.

Location

This position is based in Welwyn Relocation Assistance is not available. #MQRS

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.