Device Quality Management Systems Support - Value Delivery Lead
Together, we embrace individuality and share a passion for exceptional care. 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 the role of a Device Quality Management Systems (QMS) Support - Value Delivery Lead you have end-to-end responsibility of leading and managing the QMS aspect of medical devices and drug-device combination products across the entire product lifecycle, to deliver the pharmaceutical pipeline.This position will be part of the Global Device Quality organization.
The Opportunity:
- You will deliver a robust QMS for Medical Device requirements including developing, implementing, and maintaining global standards/SOPs (including Medical Device Quality Manual) and training materials in collaboration with Pharmaceutical Quality System (PQS) representatives, Device community, and network stakeholders
- You will ensure that applicable regulatory requirements are incorporated by monitoring and assessing impact of evolving regulations, guidance documents, health authority expectations, industry trends and Roche inspection commitments
- You will monitor and assess site implementation activities to ensure appropriateness of gap assessment/ remediation activities and determine if a network approach is warranted
- You will have experience working with relevant sections of 21CFR820 and own ISO 13485/MDSAP/MDR certification of the Medical Device QMS, including external /internal audits and support conduct of internal audits
- You will establish a process to communicate relevant changes of our Pharma Quality System (PQS) to the Notified Body and influence other PQS Squads to ensure devices are incorporated where necessary
- You will develop solutions to improve partnerships and alignment across the network
- You will develop and drive customer focused, intuitive, balanced and risk-based decisions and solutions that meet evolving business and regulatory needs
- You will lead or participate on internal cross-functional and self-managed teams using a network mindset and agile approaches to improve processes and standardize best practices by proactively providing direction and guidance to network on interpretation, understanding, and execution of requirements, and best practices for maintaining a quality program
- You will be deputy of the Management Representative per ISO13485 and 21CFR820 and a.o. responsible for preparation and execution of Management reviews and related strategy and operations. In addition, you will identify and mitigate issues & inspection risks, lead defining strategies
Who you are :
You are someone who wants to influence your own development and can work independently, with limited supervision. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies; where a job title is not considered the final definition of who you are, but the starting point
- You have a Degree in Engineering or Science discipline with 7 -10 years of experience
- You bring working experience in medical device quality functions within the combination product area, preferably in a pharmaceutical organizational setting
- You have a thorough understanding of the life science industry and specifically of combination products and medical devices.
- You bring experience with applying a risk-based approach - Risk Management
- Solid understanding of Quality Management System (QMS), including deviation and CAPA management
- You have an in depth understanding of Design Verification; Design Validation; Design Controls including Process validation/Manufacturing process control
- In addition, you will have Organizational change management, good project management skills, Drug-Device Interactions
- Understanding of quality requirements for Human Factors related activities
- Interpretation and application of Regulatory and Internal Requirements
- You have working knowledge of applicable standards and regulations e.g. ISO 13485, 21 CFR 820, EU MDR, and ISO 14971
Travel as needed (20-30%)
Relocation benefits not eligible for this position
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.
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.