Head of QA

Job description
ABC Labs was founded in Stockholm, Sweden, in March 2020, as a direct response to the unprecedented challenges of the coronavirus pandemic. ABC Labs quickly scaled to become one of the largest diagnostic labs for covid-19 in Sweden with over 3.2 million PCR tests completed and is now on a growth journey with focus on expanding its portfolio of available diagnostic tests. We are currently on behalf of ABC Labs looking for a Head of QA with the overall responsibility of helping develop, maintain, and implement quality assurance processes and systems for the laboratory practices. 

As Head of QA you will be responsible for helping design and keep updated a QMS that reflects operations of the laboratory and the company and work closely with the team on implementation of processes that reflect such QMS. You will also be leading continuous improvement activities and training of laboratory personnel and other functions in quality standards and processes. You will be in charge of reviewing and approving and follow up on all quality assurance activities on-site. You will work closely with the QA Lead/Internal Audit, Laboratory Manager, Chief Technicians and Medical Doctors.



Responsibilities
More specifically your responsibilities will include:
Main responsibility that operations are inline with the QMS.
That the QMS adequately reflects the present operations and anticipates upcoming plans. 
Act as the escalation point for all matters related to operational quality assurance and operate as a primary point of contact for QA matters internally.
Help design and be responsible for implementation of validation processes of new laboratory  procedures/methods as well as instruments.
Manage training and continuous learning. Conduct and/or oversee internal QA training.
Collaborate closely with the Laboratory Manager and Head of Laboratory Operations on operational implementation. 
Work with QA Lead to ensure operational and QMS compliance in Internal Audits. 
Participate as a member of the laboratory’s Management Team.




Qualifications
This role is suited for someone with a quality mindset that thrives in an entrepreneurial environment and likes to work in a fast-paced interdisciplinary team. You are analytical and must be able to prioritize, work efficiently, be structured, and be results-oriented.
We believe you have extensive experience from QA function from laboratory medicine. Understanding of laboratory medicine and laboratory techniques is needed.
Moreover to be successful in this role we believe you have strong organizational and time management skills, strong communication and representation skills and a collaborative mindset.
Bachelor's/Master’s degree in a Life Science related discipline
Strong QA experience
Preferably in-depth knowledge of laboratory medicine and laboratory analytical processes
Strongly meritorious if experience from fast-growing companies in highly regulated industries





Application
In this recruitment, ABC labs collaborates with Randstad Life Sciences. For further information about the assignment, please contact recruitment consultant Peter Janson.



About the company
ABC Labs was created in Spring 2020 in direct response to the unprecedented challenges of the coronavirus pandemic, as a handful of health tech entrepreneurs set out to establish rapidly scalable, state-of-the-art PCR and ELISA testing. Initially built and deployed over seven weeks, ABC has consistently represented up to 25% of all national testing for Covid-19 with over 3 million tests completed.
Our culture is defined by speed, agility, and innovation without ever compromising the highest standards of quality. ABC was first in Sweden to set up mass screening for both the Delta and Omicron variants and the first in Europe to launch tests for measuring T-cell immunity.
We believe the pandemic has changed diagnostics and healthcare forever. Looking towards the future, we are investing heavily to create solutions that make testing affordable, accessible and readily available.