Background

Elypta has discovered that a specific class of glycans in human body fluids may have clinical utility in early cancer detection. Elypta aim to be the first company to ever market an in-vitro diagnostic kit bundled with a software to measure the specific glycan profile with applications ranging from research use to clinical diagnostics. Early detection of cancer is key to improving patients’ chances of survival.

Elypta is a start-up located in Stockholm within the Karolinska Institute campus (AWL Innomedicum). Manufacturing is outsourced to Merck, US.

Elypta is now seeking a committed VP of QA/RA who will be instrumental to execute the quality and regulatory strategy in our company, manage the Quality Management System and ensure product compliance of the Elypta's tests.

This is a full time position in Stockholm, Sweden. 

Supervisor/Manager

The candidate will report to the CEO. 

Key responsibilities

• Lead and develop the quality assurance work at Elypta including the maintenance of an effective and compliant Quality Management System (QMS)
• Develop and implement quality and regulatory strategic plans
• Drive continuous monitoring and process improvements
• Ensure ongoing compliance to IVDR and ISO 13485:2016
• Ensure ongoing compliance with FDA QSR, 21 CFR Part 820 & GMP
• Ensure that validation activities are performed on equipment, processes and software used in testing of product and in manufacturing
• Liaise with Elypta's management team
• Management representative of QMS (ISO 13485:2016)
• Manage quality agreements
• Manage change control and document control
• Organize, lead and participate to internal and external audits and inspection
• Partner with software development and manufacturing subcontractor to ensure that all aspects of product development are performed in conformance to the QMS and regulatory requirements
• Partner with cross-functional leadership to ensure all aspects of product development - from kits to software - are performed in conformance to the QMS and regulatory requirements
• Prepare and perform ISO 13485 registration
• Primary point of contact for Elypta's notified body and external auditors
• Primary point of contact for regulatory authorities and internal/external stakeholders such as manufacturing and raw material subcontractors and supply chain managers
• Provide guidance on all aspects of quality within Elypta and subcontractors thus ensuring product quality and customer satisfaction
• Responsible for supply and purchasing
• Responsible for regulatory compliance
• Responsible for product registrations
• Responsible to propose and maintain the QA/RA budget

As Elypta advances, we expect the role and challenges we face to evolve, and we are therefore looking for a flexible and dedicated candidate who wantsto contribute to developing novel methods that can improve modern health care.

Required qualifications

• B. Sc., M. Sc., or Ph. D. in a relevant life science subject
• Minimum 5 years work experience including implementing and/or maintaining QMS in an ISO 13485 or FDA GMP regulated medical device industry setting
• Minimum 3 years of management experience in a medical device company (class II or class III) with both domestic and international products
• Experience in developing and delivering effective training on quality systems and processes
• Experience in performing internal and external audits, including firsthand experience of audits by regulatory authorities
• Experience in performing regulatory submissions (including to the FDA) and product registrations
• Experience with medical device software and reagent development
• In-depth knowledge, including documented training, and experience with ISO-13485, ISO 14971, GMP/GLP, QSR, 21 CFR 820, or other IVD regulations
• Proven ability to lead cross-functional teams in problem-solving and continuous process improvement

Skills and personal characteristics

• Excellent organizational skills and precision in work
• Independent and pro-active way of working
• Strong written documentation skills
• High attention to details with the ability to create clear and concise quality documentation
• Ability to complete assigned actions with high quality on a timely manner
• Openness and excellent ability to communicate with others
• Fluent in English
• Ability to work independently as well as cross-functional
• Ability to solve problems and know when to seek help
• Ability drive processes and improvements
• Strong drive and motivation for personal development
• Good computer skills