English
The company’s missions:
• Using the IMMray™ platform to develop and establish more precise and reliable tools for the early detection of complex conditions such as cancer.
• Establishing the IMMray™ based blood test for early detection in pancreatic cancer high-risk groups.
Immunovia’s strategy is to decipher the wealth of information available in blood – and translate it into clinically useful tools to diagnose complex diseases such as cancer, earlier and more accurately than previously possible. Immunovia’s unique technology platform – IMMray™ – is an antibody-based multiplex test that is designed to provide a snapshot of the immune system response – based on the information available in a single drop of blood. But IMMray™ is more than a technology, it is a systematic approach, based on cutting-edge bioinformatics, to finding the most clinically relevant changes that appear in the blood, and combining this knowledge into a “disease fingerprint” – also called a biomarker signature – that is highly specific to the particular disease.
In 2017, Immunovia, Inc. was established in Marlborough, Massachusetts. The IMMray™ PanCan-d test, the first blood-based test dedicated to the early detection of pancreatic cancer, is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information see www.immunoviainc.com. In addition to the USA, Immunovia aims to launch the test in suitable markets in Europe and Asia with the aim of providing global access to the test.
In collaboration with Create HEALTH Translation Cancer Center at Lund University and others, Immunovia also has ongoing projects in the discovery phase targeting other cancers.
Immunovia has developed since 2016 a clinical prospective study program in the three main risk groups for pancreatic cancer as follows: PanFAM- 1 is the clinical study for individuals with familial/hereditary pancreatic cancer, PanSYM-1 for patients with early non-specific symptoms suggestive of pancreatic cancer and PanDIA-1 designed for individuals at risk due to the diagnosis of new onset diabetes after the age of 50. These three large clinical studies cover today more than 10 000 subjects recruited at 30 sites in the US and Europe.
Immunovia AB was founded in 2007 by investigators from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden.
Immunovia has been a listed company since 2015, with shares traded (as IMMNOV) on Nasdaq First North in Stockholm and since April 2018 traded on Nasdaq Stockholm.
The headquarter is based at Medicon Village in Lund, Sweden and has today 60+ employees, 44 in Lund and 24 in US.
For more information, please visit www.immunovia.com
TILLSATT - QA Manager
Company: Immunovia AB
Role: QA Manager
Reporting to: QA/RA Director
Place of position: Lund, Sweden
The role as QA Manager
General description and main responsibility
As the QA Manager at Immunovia AB, you will have the responsibility for Immunovia´s Quality Management System (QMS). High emphasis will be put on QMS maintenance, interaction with relevant authorities globally, giving advice and reporting to management on QA issues.
The QA Manager has a very important function to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements. You need to be good at analyzing data and translating the outcome to actions. You will develop and manage assigned processes within the QMS, supporting the organization to continuously improve the quality system.
You will be a part of a team of four persons, working together to support the organization. Furthermore, it is part of the role to coordinate and support audits, conducted by external providers or authorities, both during audits and with follow-up of findings and corrective actions. In addition, you will also perform internal audits in close collaboration with relevant stakeholders.
We are looking for a dedicated and driven person, with excellent communication skills, as the position involves many interactions, both internally and externally. You are goal- and results-oriented, have a structured approach and enjoy working in teams.
The position will report to the QA/RA Director.
Tasks and responsibilities include, but are not limited to
• Develop and lead implementation and monitoring of companywide quality management system based on EU IVDR 2017/746, US FDA regulations and international standards such as ISO 13485 and ISO 14971
• Develop, administer, and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
• Participate actively in all stages of Design Control, ensuring quality assurance considerations and requirements are met
• Coordinate the Corrective and Preventive Action (CAPA) program
• Lead an effective Change Control process
• Implement and monitor effective and efficient quality document management process for timely processing of document changes and distribution of quality information
• Implement and monitor internal and external audit programs to ensure compliance with quality system requirements. Perform internal audits within the organization.
• Act as a company liaison during customer and regulatory quality and qualification audits and inspections. Ensure any corrective and preventive actions during external audits are communicated and implemented in a timely manner
• Arrange and coordinate management review meetings by presenting quality data with actionable information for continuous improvement and achievement of quality objectives
• Provide support for release of products
• Release of products
• Provide comprehensive Quality System Training to all employee
Requested qualifications
• MSc in natural sciences like biology, biochemistry, or chemistry
• Substantial experience from QA, QC management or similar positions within the IVD/Medical Device industry
• IT skills, proficient with Microsoft Office products
• Fluent in English and Swedish
Personal characteristics
• Driving personality with ability to prioritize tasks to accomplish goals and objectives, initiates and generates activity
• Sets clearly defined objectives, plans activities and projects well in advance and takes account of possible changing circumstances
• Ability to analyze data, interpret results and translate outcome to action such as clear recommendations to management
• Excellent communication, presentation, and intercultural skills. Gains clear agreement and commitment from others by persuading, convincing and negotiating. Ability to translate and communicate QA requirements to all staff
• Analytical with ability to tackle problems and take actions, act on opportunities, and generate new ideas
• Excellent communication and presentation skills in both written and oral forms
• Capacity to translate QA requirements into procedures in a dynamic and relevant QMS system
• Ability to work in a team and share responsibilities and tasks
• Adapts to changing circumstances and works productively in a high-pressure environment
Opportunities with the role
You will be part of a dedicated team working towards Immunovia’s vision to lead the development of bioinformatics assisted diagnosis so that all patients are diagnosed in time for effective treatment, something which in turn results in a better quality of life and significantly higher survival rates.
You will join a growing organization that puts people in focus, with an engaged management team in a company with short decision-making processes. There is an informal and personal atmosphere where each employee's contribution is important for the company's development and results. Be part of a company characterized by a fantastic team feeling and where they have mandatory “fika med knäckebröd” every day.
Immunovia is taking the next important step in bringing a solution to the unmet need of early detection of pancreas cancer to the market, by development of a world leading technology from Lund university to a clinical laboratory testing for early diagnosis of pancreatic cancer.
Contact
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Sr Recruitment Consultants at PeakSearch.
catharina.herbertsson@peaksearch.se, +46 (0)706 152 772
eva.runnerstrom@peaksearch.se, +46 (0)701 725 379
www.peaksearch.se
Application
Apply for the position at www.peaksearch.se