What are the responsibilities and job description for the Biotechnology Quality Assurance Director position at Corbus Pharmaceuticals?
**Job Overview:**
The Director, Clinical Quality Assurance will be responsible for ensuring compliance with Good Clinical Practice (GCP) regulations and guidelines. This includes managing the GCP Quality interface, conducting audits, and reviewing clinical study reports.
**Key Responsibilities:**
- Manage the GCP Quality interface to ensure compliance standards are achieved
- Conduct routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents
- Review and approve Clinical SOPs and develop Clinical QA SOPs
- Develop and implement detailed audit plans and yearly GCP audit schedules
- Ensure timely and effective follow-up of all identified or assigned quality issues
**Requirements:**
- Bachelor of Science degree in a relevant field, such as Biology, Biomedical Engineering, or Engineering
- 12 years of relevant work experience in the GxP (GCP heavy) Biotechnology/Pharmaceutical industry
- Knowledge of GCP FDA, MHRA, and EMA regulatory requirements applicable to Biologics therapy products
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