Job Description

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 peoples varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position A healthier future. Its 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. Thats what makes us Roche. In Product Development Quality (PDQ) we take an innovative approach to 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), Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes. We are looking for a Quality Lead (based in Welwyn or Mississauga) to join our R&D Quality (Product Development Quality) team! We are recruiting for roles both in our Quality Assurance (GCP) Programs and Quality Assurance (GVP) Process teams. The Opportunity The Quality Assurance (GCP) Programs and Quality Assurance (GVP) Process teams actively lead or contribute in activities to assess Quality Assurance status, such as audits, and evaluation of actions taken, preparation and presentation of Quality Brief conclusions (contextualized quality evidence), to business stakeholders and Pharma representatives and ensure appropriate action plans have been developed and determine acceptability of evidence of compliance. In addition,these teams provide leadership for key roles in major Health Authority inspections (e.g FDA, EMA), including inspection readiness and inspection management activities. Who you are

• You are an experienced quality professional, drug safety/pharmacovigilance or clinical operations professional with a strong understanding of risk-based critical thinking.
• You bring innovation, strategic data-driven decision making, and diversity to your day to day work.

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

• You have a proven track record in major Health Authority inspection leadership (e.g FDA, EMA), including inspection readiness and inspection management activities.
• You can comfortably lead discussions and decisions related to clinical and/or pharmacovigilance risk with Senior Management, actively contributing to a Culture of Quality.

Ad hoc travel is required to support regulatory inspections. Relocation benefits are not available for this posting
Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture. As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.



Roche is an Equal Opportunity Employer.