Walla Walla, Washington
Poplar Bluff, Missouri
Posted: 13-Jan-25
Location: Fitchburg, Wisconsin
Type: Full Time
Salary: To be discussed
Categories:
Required Education:
Internal Number: 3954
Director, Quality Assurance- Usona Institute
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 science field
- 12+ years of relevant hands-on experience in GxP, QA leadership positions in the Biotech and/or pharmaceutical industry.
- Extensive knowledge and experience with GCP regulations and clinical study quality assurance, including experience in auditing clinical trials and ensuring compliance with regulatory bodies such as the FDA, EMA, or other health authorities.
- Extensive knowledge and in-depth experience of implementing Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for US, 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 collaborative, hands-on leader with proven experience fostering a culture of teamwork and inclusion, inspiring and empowering team members to achieve both individual and organizational goals.
To apply, view a complete job description, and learn more about our company, please visit:
https://careers-usonainstitute.icims.com/jobs/3954/director%2c-quality-assurance/job
Only applications received through our website will be considered.
Additional information about Usona can be found at www.usonainstitute.org.
Diversity is important at Usona. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.