Quality Solutions Lead

1 week ago

Mississauga, Canada Roche Full time

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Quality Solutions Lead, PDQ

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 team who bring a diversity of thinking and technical experience in various Quality disciplines e.g 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, 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.

Additionally:

  • 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.

The Product Development Quality organization defines success for these roles through the following 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.

Your Application

Please provide your current compelling CV & 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.

We are looking forward to your application

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.

Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment.

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