Data Quality Solutions Expert

1 week ago

Welwyn Garden City, Hertfordshire, United Kingdom F. Hoffmann-La Roche Gruppe Full time
About the Role

F. Hoffmann-La Roche Gruppe is committed to fostering a culture of diversity, equity, and inclusion, reflecting the communities we serve. In the context of global healthcare, diversity is a vital component of success. We believe that inclusion is essential to understanding the varied healthcare needs of individuals. Our organization values individuality and is passionate about delivering exceptional care.

The Position

Quality Solutions Lead, PDQ

In Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unparalleled transparency with health authorities, patients, and society. Our work provides leadership, expertise, and partnering on quality across molecules (GCP/GVP), products (drugs and/or medical devices/in-vitro diagnostics), pharma affiliates, and global regulated processes.

We are seeking experienced Quality Solutions Leads to join our Quality Solutions team, bringing diverse perspectives and technical expertise in various quality disciplines, such as GCP, GVP, medical device/IVD.

Your Profile & Key Responsibilities

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 any of the following areas: GCP, MDR/IVDR, and SaMDs, GVP, RBQM, Risk Management, QMS.
  • You have demonstrated experience in leading large projects within a matrix environment, 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.

Additionally:

  • You have a solid understanding of drug or medical device development, clinical trials, and the processes and regulations that support these.
  • You have a proven track record of process design, development, and deployment.
  • You have the 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.
  • You have the 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.
Key Competencies
  • Critical thinking
  • Change mindset
  • Communication
  • Data-driven decision making
  • Problem-Solving (curiosity, creativity, and adaptability)
  • A proactive risk-based approach and enterprise-wide mindset
  • An innovative approach
  • Stakeholder engagement and management
  • Influencing and negotiation
  • Inclusive leadership, coaching, and mentoring
  • Strategic decision making (focus on the work that adds value)
  • Maximizing and enabling results with velocity
Application Process

Please provide your current compelling CV and Cover Letter. The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.

The role will be based at our Welwyn or Mississauga sites. Please note that we are not able to provide any relocation benefits; therefore, you must hold the right to live and work in the country you are applying for. Some travel might be required to support global projects.

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