Would you like to be part of a dynamic and exciting team delivering high level performance that has a direct impact on the lives of cancer and rare disease patients worldwide? Join our growing team and use your exceptional technical and organizational skills to help us deliver on our mission of democratising Data-Driven Medicine. Our products are used by over a thousand healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.
Be part of our mission to disrupt the healthcare and democratize the data driven medicine! SOPHiA is looking for a Quality Director, Strategic Partnerships, to join the Global QA/RA organization.
Reporting to the SVP of Regulatory Affairs and Quality Assurance, you will drive the development, assessment,recommendations and implementation of Quality amp; Regulatory aspects of strategic partnerships in a medical device regulated industry. As a key member of project and integration teams, you will be responsible for recommending quality and regulatory strategy to ensure mutually beneficial and compliant development paths.
To successfully achieve the objectives of this role you pose strong leadership skills to execute large, complex and cross-functional initiatives in order to drive quality and regulatory strategy in line with SOPHiA GENETICS mission and partnership goals while maintain compliance with FDA QSR, ISO 13485, ISO 27001 and IVDR/MDR regulations.
Mission
- Represent SOPHiA Quality amp; Regulatory in strategic partnerships
- Develop actionable QA/RA strategy and plans to achieve partnership goals and monitor to completion
- Negotiate Quality Agreements with key partners and suppliers
- Participate in Regulatory Inspections or Quality Audits (internally and externally) as necessary relating to partnerships/alliances to ensure successful business outcomes
- Collaborate with Business Development to ensure that Quality or Regulatory concerns are addressed early in partnerships and that a resourcing strategy is developed
- Participate in the development of new partner strategic plans
- Work with peers within the QA/RA organization to ensure long range resource planning and skills development as needed to achieve partnership goals
- Responsible for the execution of QA/RA projects necessary to achieve corporate and departmental goals.
Requirements
- 10+ years of relevant experience in quality/regulatory affairs for medical device or In-Vitro Diagnostic company. Experience with pharmaceutical companies a bonus.
- Bachelor’s degree in engineering, science or other technical field. Master’s degree preferred.
- Demonstrated experience of key regulations and standards (ISO 13485, FDA CFR, EU MDR/IVDR, ISO 27001, etc.).
- Executive communication skills; proven ability to communicate key messages to senior leadership audiences and effectively manage key stakeholders
- Proven ability to effectively build partnerships and take a relationship-based approach in working with internal and external stakeholders
- Experienced in collaboration techniques and ability to facilitate partnerships
- Multicultural savvy experience working across regions, countries and cultures
Fluent in English (spoken and written) alternate language fluency is a plus
Benefits
- Career opportunities in a fast-growing company with worldwide reputation
- A flexible and friendly working environment with a collaborative atmosphere
- Fantastic office locations in Switzerland
- An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
- A fast-growing company with plenty of opportunity for personal growth and development
Start: ASAP (or as agreed)
Contract type: permanent full-time
Application process
If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.
After an initial screening process, candidates will be invited for remote interviews. Selected candidates will then be invited for personal interviews.