Senior Quality Solutions Lead

Roche; Plymouth; On-site; GBP 50,000 - 70,000; Full time

Job summary

Roche seeks a Quality Solutions Lead to enhance healthcare access through innovative quality solutions. This role involves collaborating with experts to ensure effective quality management systems and leads large projects while fostering decision-making and communication. Ideal candidates exhibit strong experience in GVP and QMS, with proven skills in critical thinking and problem solving.

Qualifications

• Strong experience in GVP and QMS.
• Understanding of drug/medical device development and clinical trials.
• Experience in process design and deployment.

Responsibilities

• Lead the design and delivery of quality solutions.
• Manage the Quality Management System effectively.
• Facilitate decisions and ensure effective stakeholder engagement.

Skills

Critical thinking

Problem solving

Digital literacy

Relationship management

Education

Bachelor's degree

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

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.

Creating a world where we all have more time with the people we love.

That’s what makes us Roche.

In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules (GCP/GVP), Products (Drug and/or Medical Devices/In-Vitro Diagnostics), Pharma affiliates and global regulated processes.

We are looking for experienced Quality Solutions Lead(s) to join our Quality Solutions GVP team who bring a diversity of thinking and technical experience in various Quality disciplines e.g GVP, GCP, medical device/IVD.

We are looking to hire dynamic and quality driven individuals in either our Mississauga or Welwyn Campus.

The Opportunity:

As a Quality Solutions Lead, you will collaborate with a team of experts and peers across the organization to identify, design, and deliver quality solutions. Your role will be pivotal in the delivery and maintenance of an adequate, suitable and effective Quality Management System (QMS).

You are a highly motivated and committed professional with strong experience and technical knowledge in GVP, QMS and any of the following areas: GCP, MDR/IVDR and SaMDs, RBQM, Risk Management.

You have demonstrated experience in leading large projects within a matrix environment, whilst facilitating decision making and communications, with strong digital and data literacy.

You have proven critical thinking and problem solving skills (curiosity, creativity and adaptability), with solid relationship management and influence. You ask challenging questions and are comfortable in difficult conversations.

Who you are:

You have a bachelor's degree completed with relevant industry experience.

Solid understanding for drug or medical device development, clinical trials, and the processes and regulations that support these.

Proven track record of process design, development and deployment

Ability to develop QMS process strategies and manage timelines to ensure successful oversight and delivery of quality solutions.

You actively lead or contribute in activities to enable process delivery end-to-end, including but not limited to impact assessments, procedural document delivery, learning design and delivery

Ability to understand and analyze emerging regulatory and business requirements and expectations and interpret and implement into processes

You comfortably lead discussions of unresolved issues and manage stakeholder relationships at every level.

Relocation benefits are not available for this job posting.

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.

About the company

606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

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