Global head of Regulatory Affairs & Quality Assurance
Ranked among the "50 Smartest Companies" in the world according to the MIT Technology Review, SOPHiA GENETICS is a fast-paced, high-growth health-tech company. Combining deep expertise in life sciences, medical disciplines and mathematical modeling, we bring to market data analytics solutions to support healthcare professionals in better diagnosing and treating patients. Today SOPHiA’s products and services are trusted by over 1,000 leading hospitals and laboratories worldwide, connected to each other and motivated by the goal of providing better outcomes to all patients.
As we further our mission to democratize data-driven medicine worldwide, we are looking for a Global Head of Regulatory Affairs & Quality Assurance. It is a rare opportunity to shape the future of a company that is young, successful, international, and on a world-changing mission. You will have the opportunity to work from our US offices in Boston or Denver (CO) or from our HQ in Lausanne, Switzerland.
You will be managing a team of talented RA and QA experts based in Europe and the USA. The main goal will be to implement a new strategic approach for regional and country-specific regulatory submissions to ease the regulatory approvals process and maximize the commercial success of SOPHiA GENETICS products and services around the world. As global head of Quality Assurance, you will be leading all aspects of QA/QC to ensure product quality and customer satisfaction. You will be driving the seamless integration of our quality objectives into our core processes. As the Head of RA & QA you will also be responsible for overseeing and directing our suppliers and procurement function.
If you have the skills, the experience and the passion, we would love to hear from you.
Directly to the SVP, General Counsel.
Key Responsibilities and deliverables
- Develop, align and implement a global strategy for regulatory filings and compliance.
- Direct, oversee and optimize the development and implementation of regulatory solutions and strategies for new product/features/services registrations.
- Plan, prepare and project manage regulatory submissions.
- Shape an effective and scalable filing strategy for the USA (FDA) and Europe (MDR/IVDR) and interact with regulatory authorities, notified bodies, advocacy groups and others.
- Facilitate global product registrations by ensuring smart and effective design and development of technical documentation for submission to local regulators.
- Develop global compliance program to ensure compliance with applicable regulatory requirements with various internal stakeholders: Product Development, Data Science, Quality, Supply Chain, Sales, Marketing and IT and Operations.
- Act as a strategic partner to the Executive leadership team for regulatory aspects related to commercialization, marketing, product development and business development.
- Develop close working relationships internally to facilitate seamless regulatory support for all ongoing and future business of SOPHiA GENETICS around the world.
- Lead interactions with regulatory agencies and other external partners.
- Monitor regulatory agencies for changes in policies and procedures and implement changes as required to maintain registrations, maintain knowledge about applicable standards, directives and guidance’s necessary to facilitate notifications and submissions to regulatory agencies
- Provide regulatory guidance and expertise, and train staff on regulatory procedures.
- Develop a Quality Assurance strategy and organization to ensure that quality objectives are fully integrated in the company’s core processes.
- Lead and oversee the Quality Assurance program and continuously evaluate, propose and implement new processes and technologies to optimize efficiencies in the Quality function and the Quality Assurance program.
- Ensure the Quality Management System is kept up to date, and identify and initiate improvements to SOPHiA GENETICS’ global Quality Management System ensuring compliance with applicable quality and regulatory requirements.
- Ensure that ISO certifications remain valid.
- Ensure that processes needed for the Quality Management System are properly documented and that staff is properly trained;
- Report to Executive management on the effectiveness of the quality objectives of the company and any need for improvement;
- Ensure the promotion of awareness of applicable regulatory requirements and Quality Management System requirements throughout the organization.
- Ensure CAPA’s are properly managed and appropriately followed-up.
- Provides guidance and oversight for any recalls, complaints, and quality/regulatory reporting.
- Manages and leads the Regulatory Affairs & Quality teams in the US and Europe.
- Develops, drives and supports the team through regular assessments.
- Assigns training necessary to continuously grow the team’s expertise.
- Involved in the hiring process and team organization to create a high-performance team.
Knowledge, Skills and Experience Required
Education and technical knowledge
- Masters’ degree in life sciences e.g. biology, pharmacy, biotechnology, preferably in combination with an MBA.
- Proven track record in Regulatory Affairs management, healthcare product life cycle management, product development, QA/QC of IVDs and MDs.
- A working knowledge of ISO 13485 and ISO 14971, FDA QSR, the GxP standards, and the EU MDR and IVDR, with previous experience of working in a senior quality role within the Medical Devices or Pharmaceutical Industry.
- Software Development and Validation experience including CSV.
- Experience in Product Development, Product and Process validation, statistical analysis and process capability studies.
- A working knowledge of Kaizen, Six Sigma, Lean, Problem solving, Continuous Improvement methodologies, or other project management tools and techniques.
- Fluency in spoken and written English, French an asset.
- Minimum 15 years of relevant experience in the healthcare industry. Experience in biotech, oncology and hereditary diseases and/or Software as Medical Device an asset.
- Experience of influencing people with a demonstrable track record of making a difference within an organization.
- Ability to leverage relationships across other departments and with prioritization.
- Proven record of influential business development, strategic planning, organizational development, project management and negotiating skills.
- Excellent understanding of customer relationship management and customer service
- Experience in CAPA management and change control.
- Extensive knowledge of Quality Systems management.
- Experience with strategic regulatory agencies submission.
- Must use initiative, be proactive and have good follow-up skills.
- Socially minded team leader with a positive mindset.
Location : Switzerland (Lausanne)