Usona Institute, a non-profit medical research organization founded in 2014, conducts and supports biochemical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Our focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life.
The Director, Quality Assurance is responsible for the strategic development and execution of Usona’s quality assurance program including all quality-related decisions. This position reports to the Executive Director for the execution and administration of all GXP Quality Systems and is directly accountable for cGMP, GLP, GCP and GVP compliance in accordance with ICH, US, EU, and other relevant regulations. This position is expected to lead a team and collaborate across the organization on all quality matters and develop strong relationships with external consultants and contractors as necessary to support QA activities and responsibilities. The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and relevant regulations across multiple jurisdictions. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing Usona’s impact within its field of research.
Our ideal candidate will have:
Bachelor’s degree, preferably in the life sciences.
15+ years of relevant experience in GXP, QA leadership positions in a Biotech and/or Pharmaceutical industry.
Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities.
Familiar with ICH Quality Guidelines and a demonstrated ability to utilize ICH Q9/Quality Risk Management principles in everyday practice.
A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members.
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We are Promega: an international bio-tech company made up of scientists and non-scientists, with over 4000 high quality products that have been sparking inspiration and discovery in science for over 40 years. We support scientists researching life and disease, pharma companies developing new treatments, forensic labs matching DNA from crime scenes and clinical labs running and confirming health tests – and that’s just the beginning. Just this past year, we provided our technologies to support COVID-19 testing and research.