Director of Quality (f/m/d)
ATAI Life Sciences
The Quality Director at atai will be the QA subject matter expert, supporting GxP activities across the atai platform – interpreting GxP regulatory documents to facilitate compliance, audit success, and process improvement. The role will be responsible for the selection and management of the Quality Management System across atai and its subsidiaries. This role will report to the Senior Director of Business Operations and be a member of the Operations Chapter.
atai's Operations Chapter is responsible for leading and coordinating our subsidiary assets, our overarching operating model, data infrastructure, and product supply. Through smooth execution of our development programs, the team is crucial for the success of atai. Furthermore, they enable efficient processes, clarify responsibilities, and manage our strategic vendors.
Who we are:
atai Life Sciences is a biopharmaceutical company focused on developing novel treatments for mental health disorders so that everyone, everywhere, can live a more fulfilled life. To achieve this, we are developing psychedelic and non-psychedelic compounds and cutting-edge digital therapeutic tools, and we are excited about anything that might mean a true leap forward for our patients. We operate a hybrid virtual/in-person working model, with most of the team spending 2-3 days in the office, and our hubs are located in Berlin, New York City, and San Diego.
What we offer:
- Compensation package inclusive of yearly bonus and generous stock options
- Annual company offsite retreat in U.S or Europe
- Hub visits to our offices in Berlin, New York City, and San Diego
- Hybrid work model with 2-3 days in office, and home office budget
- Mental health wellness program, including 10 company-paid therapy sessions a year
- Sports Club membership (Class Pass, Urban Sports Club)
- 50% medical insurance contribution for DE
- 100% employer-matched pension scheme for DE
What you will achieve:
During your first 6 months, you will have selected and implemented the eQMS, finalized all high-priority GxP SOPs, and implemented a GxP document training plan. In your first 6-9 months, you will have conducted gap analysis and risk assessment of all GxP activities and identified process improvements (internally and with vendors). By the end of your first year, you will have successfully embedded Quality Assurance into the DNA of atai – forging excellent working relationships across atai and its subsidiaries.
The specifics of your day-to-day will include:
- Quality champion - providing leadership and SME guidance, to atai and its subsidiaries, to ensure compliance with GxP requirements (e.g., GLP, GCP, GDP, GMP, ERES. Part 11, Annex, etc.)
- Keep atai & its subsidiaries informed of changes in GxP requirements
- Lead the selection, implementation, and maintenance of the electronic Quality Management System (eQMS)
- Author and review GxP documents, (e.g., SOPs, change control, risk assessments), and manage Corrective and Preventable Actions (root cause determination, verification, and closure)
- Lead GxP training and ensure fit-for-purpose training modules for GxP personnel
- Lead and support audits and inspections, including from regulatory authorities, audits to support vendor selection and investigator site audits
Qualifications / experience that we'd like to see:
- BSc or MSc in biopharmaceutical or biomedical science, chemistry, pharmacy, or another relevant Life Science degree
- Minimum of ten years of experience in pharmaceutical/biopharmaceutical GCP and GMP quality assurance environments with experience in both EU and US (additional experience in GLP appreciated)
- Experience working in drug development utilizing controlled substances is preferred
- Experience working in a high-growth or start-up environment is preferred
- Proven experience in leading and conducting investigator site audits, quality control of clinical study reports, clinical database audits, in-house clinical file audits, GMP batch record reviews, and approval, vendor qualification audits, and experience with PPAs
- Experience with evaluating and implementing an eQMS, including educating GxP personnel about quality requirements and appropriate scale-up to align with the company’s drug development programs
- Ability to effectively present information to management and communicate across all levels of the organisation
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
Who will be successful in this role:
Those who succeed at atai will be strongly aligned with our values:
- ❤️ Conscious Care: We take every action in service of our ultimate goal: to heal mental health disorders for all while caring for ourselves and our team.
- 🦸 Bold Entrepreneurship: We are “loosely coupled but tightly aligned” as we strive for excellence over perfection, fast and focused to accelerate innovation for patients.
- 🧑🤝🧑 Collaborative Innovation: individuals and teams work together with good humor and no drama, valuing different perspectives and diversity of thought, background, nationality, and style.
- ✋ Radical Responsibility: We take full responsibility for our circumstances. We grow and learn from failures, always looking to improve.
At atai, we value diversity of thought, background, and experience. We encourage applications from everyone everywhere – especially women, people of color, and members of the LGBTQIA+ community.
Research shows that members of minority groups are less likely to apply for a job unless they believe they meet all the requirements listed. Even if you feel that you do not meet 100% of the job criteria, we’d love to hear from you.
You might be a great fit for another position now, or in the future. We look forward to hearing from you!
Check out the video below to learn more about why we do what we do!
**No Recruiters Please**