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. 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.

The Opportunity

The Device Quality Complaint Operations team is accountable for the Quality management of Global Complaints for stand alone medical devices (e.g. Port Delivery Platform) and device constituent part of combination products. The Chapter responsibilities also include global complaint operational activities (e.g. quarterly trending) and support of continuous improvement initiatives for the medical device complaint management process.

• Develop the strategy and architecture for a scalable complaints process ensuring the right infrastructure for riskbased decisionmaking. Build a workforce with the right competencies to deliver on devicerelated priorities
• Simplify processes and lead data governance in the complaints process to enable digital solutions such as AI and other automation technologies
• Architect and oversee a complex outsourcing model for handling highvolume complaints. Hold endtoend accountability for the Chapter teams performance and delivery
• Ensure team members have the required proficiency to execute tasks and meet objectives. Promote continuous improvement and advance behavioral capabilities through coaching in new working approaches
• Partner with other Chapter Leads to align on strategic priorities accelerate decisionmaking and support each other. Act as a strategic partner to stakeholders in PTQ and PT for organizational priorities
• Develop and manage the annual budget revising forecasts as needed and monitor expenditures for efficient resource use. Optimize the PTQ DQ operating model and identify organizational efficiencies
• Advance diversity equity and inclusion within the team. Collaborate with other Chapter Leads for talent flow succession planning and addressing business requirements. Promote a safe environment for experimentation and autonomous contribution

Who you are

• Holds a BA or BSc degree (or equivalent) in life sciences Pharmacy or a related scientific discipline
• Bring twelve years of experience in a regulated industry such as pharma/biopharmaceutical or medical device with 7 years in Quality Compliance Regulatory and/or Validation (particularly in complaint and adverse event management). Possess a strong understanding of quality assurance concepts including cGMP GSDP and GVP
• Experience with medical devices multiple manufacturing technologies and understanding of product lifecycles is desirable enhancing the ability to manage diverse technical challenges
• Demonstrate significant experience in leading teams in a matrix environment. Show evidence of the ability to develop employees through lateral or promotional movements internally or externally
• Embrace a mindset of inclusivity speaking up coaching others focusing on outcomes continuous learning and shared accountability. Act as a Visionary Architect Coach and Catalyst to foster a diverse and inclusive culture connect people and help achieve ambitious goals

Who we are

A healthier future drives us to innovate. Together more than 100000 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 lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

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 Roches truly innovative culture.