Elypta’s mission is to prevent mortality from cancer through early detection and closer monitoring. Ongoing trials co-directed or sponsored by Elypta are investigating the use of new blood and urine molecular diagnostic tests for early cancer detection. We are looking for a passionate VP of QA/RA to join the team and bring Elypta’s tests to the market.
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.
The candidate will report to the CEO.
- 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.
- 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
Apply by sending a CV and cover letter to Eleanor Doolin, Charlton Morris:
Employment starts at earliest possible date.