Director, Clinical Quality Assurance
New
B
Braeburn Pharmaceutical
Remote or Plymouth Meeting, PA (Hybrid)Full-TimeDirector
Salary not disclosed
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Job Details
- Experience
- At least 10 years of Quality Assurance experience in pharmaceutical GCP operations
- Required Skills
- GCPQuality Assurance
Requirements
- BA/BS in related field.
- At least 10 years of Quality Assurance experience in pharmaceutical GCP operations or related quality technical role in the medical space.
- Robust understanding of quality management systems and GxP.
- Deep knowledge of international guidelines ICH-GCP as well as relevant local regulations.
- Strong experience in QA Audits of Clinical sites and Third-party organizations.
- Significant experience with QA review of Clinical Protocols, CAPA reports, SOPs, change control processes, and deviation/investigation reports.
- Experience with computer systems validation and QA agreements.
- Expertise in leading regulatory health authority inspections.
- Proven ability to lead and influence cross-functional employees.
- Excellent critical data analysis, written, and oral communication skills.
Responsibilities
- Lead all Clinical Quality Assurance (QA) activities within the company.
- Develop, implement, and maintain all clinical quality assurance systems, processes, and procedures.
- Develop and track clinical quality metrics, approve deviations, and develop Corrective and Preventative Actions (CAPAs).
- Lead management review meetings and ensure continuous improvement.
- Maintain inspection readiness for sponsor and regulatory inspections (FDA, EMA).
- Qualify and audit CROs and clinical suppliers per internal SOPs.
- Monitor CRO performance and ensure compliance with GCP and company standards.
- Implement proactive risk identification and mitigation processes.
- Build and roll out QA training programs for internal staff and CRO partners.
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