Are you a passionate and experienced QA professional with a desire to make a significant impact in cell-based therapies? A clinical-stage biopharma company is currently seeking an Associate Director of Clinical QA to join their innovative team full-time.
Responsibilities:
- Lead the development and implementation of an effective and phase-appropriate vendor quality oversight program in compliance with domestic and international regulations.
- Establish and execute vendor qualification and audit processes for GxP external vendor oversight.
- Conduct virtual and on-site audits of GCP and GCLP vendors.
- Oversee the preparation of qualification reports and corrective action plans, including risk management strategies.
- Create a system for tracking audit observations and ensuring the implementation of corrective actions at vendor sites.
- Collaborate with SMEs to design and execute annual audit plans.
Qualifications:
- Bachelor's or Master's degree in the life sciences.
- 10 years' experience minimum in the pharma or biotech industry, with significant GCP and GCLP QA experience.
- Prior experience as a lead auditor conducting GCP and GCLP vendor audits.
- ASQ-CQA certification preferred.
- Familiarity with domestic and international regulations, including 21 CFR, ICH, and ISO standards.
- 30% domestic and international travel.
