R&D Quality Lead

Roche; Plymouth; On-site; GBP 45,000 - 65,000; Full time

Job summary

Roche is seeking an Associate Quality Lead responsible for enhancing quality outcomes in Product Development. The role requires expertise in various quality management areas and the ability to adapt and solve problems in an international setting. Join a company committed to innovating healthcare solutions for a healthier future.

Qualifications

• Technical expertise in GCP, GVP, MDR, SaMDs, QMS, or RBQM.
• Demonstrated adaptability in challenging situations.
• Skilled in influencing and negotiation.

Responsibilities

• Support development and implementation of quality strategies.
• Provide quality data to meet regulatory requirements.
• Contribute to international projects ensuring alignment.

Skills

Critical thinking

Problem-solving

Stakeholder engagement

Digital Literacy

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 aim to deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. As an Associate Quality Lead , you will play a pivotal role in driving excellence across our global quality landscape, from Good Clinical Practice (GCP) and Pharmacovigilance (GVP) to Medical Device Regulations (MDR) and beyond. This is your chance to shape quality strategies and deliver impactful results for Roche’s portfolio of work.

Key Responsibilities

• Supports the development and implementation of strategies to enhance outcomes, productivity, and efficiency across Product Development Quality (PDQ).

• Provides quality data to meet regulatory requirements while generating insights to catalyze key decisions.

• Contributes to large-scale projects in international, multicultural matrix environments, ensuring alignment across the business.

• Design and maintain methodologies for data analytics and regulatory compliance tools.

• Apply knowledge management and organizational learning to deliver sustainable improvements.

• Contribute to portfolio management, capability development, and the nurturing of organizational quality skills.

Who You Are

Essential Skills and Experience

• Desired technical expertise in areas like GCP, GVP, MDR, SaMDs, QMS, or Risk-Based Quality Management (RBQM).

• Demonstrated critical thinking, problem-solving, and adaptability in challenging situations.

• Skilled in stakeholder engagement, influencing, and negotiation.

• Digital and data-literate, with the ability to apply insights for impactful outcomes.

Competencies You'll Demonstrate

• Critical thinking and a proactive risk-based approach.

• Inclusive leadership with a focus on coaching and mentoring.

• Strategic decision-making aligned with business value.

• A change mindset and an innovative, data-driven approach.

• Exceptional communication and collaboration skills.

Please kindly provide a cover letter alongside your CV.

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