Associate Director of Quality Assurance, Analytical and Client Services
Serán BioScience(1 month ago)
About this role
The Associate Director of Clinical Quality Assurance at Serán BioScience provides strategic leadership for clinical quality assurance, ensuring quality and compliance are embedded across operations and long-term quality strategy. The role oversees end-to-end harmonization of quality processes, including risk management and GMP core management, aligned with global regulatory requirements. It is responsible for maintaining an effective quality system from development through commercialization for products manufactured at the Bend, Oregon site. The position also leads the Clinical QA department and serves as a key liaison for audits, inspections, and client-facing quality activities.
Required Skills
- Risk Management
- Quality Strategy
- GMP Compliance
- Regulatory Compliance
- Quality Systems
- Facility Validation
- Documentation Management
- Audit Support
- Quality Management Review
- Change Control
+20 more
Qualifications
- Bachelor’s Degree in Scientific Discipline
About Serán BioScience
seranbio.comSerán Bioscience is a science-driven drug development company that uses a research-first approach and advanced drug‑delivery technologies to enable and enhance clients’ medicines. They partner with biotech and pharmaceutical teams to translate therapies from concept toward clinical readiness, focusing on formulation and delivery solutions that improve patient outcomes. Headquartered in Bend, Oregon, Serán emphasizes rigorous science and collaborative development to accelerate programs and de‑risk therapeutic candidates.
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