Cybin has an exciting opportunity for a Director, Quality Assurance to join the growing team!
A leading biotechnology company, Cybin is focused on and dedicated to progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric disorders. To learn more about Cybin, visit https://www.cybin.com.
Reporting directly to the SVP, Quality Assurance & Regulatory Affairs, the Director of Quality Assurance is responsible for all aspects of quality from R&D through Commercialization, including creation of Cybin’s Quality Management System. This role will ensure Cybin remains fully compliant with all applicable regulations while pursuing its enterprise ambition to transform mental health therapies. The Director, Quality Assurance will represent Cybin with strategic partners and regulatory authorities and foster collaborative, effective relationships.
This position can work remotely or out of our Toronto, Boston or Seattle offices.
- Responsible for the operational strategy and overall execution of Phase 1, Phase 2, and Phase 3 clinical programs with psychedelic therapeutics, which includes scope, quality, budget, time, resources, and risk
- Drives an organizational wide culture of Quality in partnership with the Management Team and functional leaders.
- Builds a dynamic Quality strategy focused on driving transformative psychedelic compounds through the clinical phase to commercialization.
- Develops and implements the Cybin Quality Management System built on best-in-industry, lean, effective processes.
- Ensures all Cybin activities are performed in compliance with applicable cGxPs.
- Performs vendor qualifications and creates collaborative, effective relationships with the respective QA Heads.
- Lead the development of Quality metrics and the respective periodic reporting.
- Prepares for and successfully manages regulatory agency inspections and inquiries.
Knowledge, Skills& Technical Abilities
- BS in Science with an advanced degree preferred.
- 15+ years of Pharmaceutical QA experience, with demonstrated growth in responsibilities and expertise, covering R&D through Commercialization.
- Proven ability to design, develop and administer a lean and effective QMS.
- Comprehensive experience in the technical aspects of cGxP including US FDA, EMA, and ICH regulations related to biopharmaceuticals and combination products.
- Outstanding self-starter with dynamic communication and influence skills.
If you are passionate about pursing this position, please submit your resume and cover letter as one attachment to firstname.lastname@example.org no later than April 16th, 2021. Cybin Inc. is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to ethnicity, color, national origin, age, religion, sexual orientation, gender identity or expression, family or parental status, veteran status, neuro diversity status, disability status or any other basis protected by applicable law. We are proud to provide employment accommodation during the recruitment process. Should you require an accommodation, please contact us at HR@Cybin.com and we will work with you to meet your accessibility needs. We welcome applications from all qualified candidates. We thank all those who apply. However, only those selected for an interview will be contacted.