Clinical Quality Assurance (CQA) Manager role at Aurion Biotech, a clinical-stage biotech company developing regenerative therapies. The role is responsible for leading and overseeing the CQA strategy in support of clinical study conduct, ensuring compliance with regulatory requirements and company policies.
Requirements
- Bachelor’s degree in Biology, Chemistry, or other relevant scientific discipline required
- Minimum of 8–10 years of experience in the pharmaceutical/biotech industry
- At least 5 years specifically in a GCP Quality Assurance lead role
- Direct experience with Cell Therapy clinical studies is preferred
- Proven track record of leading or playing a major role in successful regulatory inspections (FDA/EMA)
- Expert Knowledge: Deep mastery of 21 CFR Parts 11, 50, 54, 56, 312, and ICH E6 (R2/R3)
- Decision Making: Ability to make complex, risk-based decisions in a fast-paced environment with a sense of urgency
- Communication: Exceptional verbal and written communication skills, with the ability to influence cross-functional stakeholders and external partners (CROs)
- Vendor Management: Experience managing and auditing large-scale CROs and other Clinical vendors
Benefits
- Full health insurance to employees and their families
- 401(k) matching
- EAP (Employee Assistance Program)
- FSA (Flexible Spending Account)
- Generous PTO (Paid Time Off)
