Director Clinical QA
4 weeks ago
Director, Clinical Quality Assurance
Location: Boston, Massachusetts
Albion Rye Associates, a reputable staffing agency within the healthcare sector, is collaborating with a leading US Biotech company in Boston. They are seeking a skilled Director / Senior Director in Clinical Quality Assurance to join their team.
In this role, you will oversee a small team and play a crucial part in the Quality Assurance management by serving as the Lead GCP Auditor, reviewer, and mentor.
Responsibilities:
- Develop and implement QA compliance programs
- Conduct audits for investigator sites, service providers, and internal processes
- Enhance SOPs for GCP/GLP/GVP QA procedures
- Ensure compliance and represent QA within the organization
- Establish and nurture relationships with both internal and external stakeholders
- Lead cross-functional projects
- Provide compliance guidance and support during inspections
- Contribute to regulatory inspection preparations
- Identify areas for quality system enhancements
- Assist in developing strategic procedures for continuous quality improvement
- Establish quality metrics and reporting mechanisms
- Provide training and stay updated on GCP/GLP/GPV requirements
Qualifications:
- Bachelor's degree required; master's degree preferred
- Minimum of 8 years of experience in the biotechnology/pharmaceutical industry
- Strong knowledge of drug development process and FDA regulations
- Experience in INDs, CTAs, BLAs, MAAs, and NDSs submissions
- Proficiency in electronic clinical database software and Microsoft Office
If you are interested in the Director, Clinical Quality Assurance position, please reach out to the recruiting team at Albion Rye Associates.
Join a dynamic team in a fast-paced Biotech environment with exciting opportunities for career growth and development.
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