Remote Clinical Quality Assurance Leader

Jazz Pharmaceuticals; Philadelphia (Philadelphia County); On-site; USD 184,000 - 276,000; Full time

Job summary

Jazz Pharmaceuticals, a global biopharma company, is seeking a Director of Clinical Quality Assurance to ensure GCP compliance across clinical development and trials. The role leads the CQA function and champions quality improvements.

You will drive risk-based quality activities, oversee CRO/vendor compliance, and collaborate with cross-functional teams to uphold standards and inspections readiness in regulated drug development in the United States.

Qualifications

• Typically 14+ years relevant work experience in the Pharmaceutical or Biotechnology industry.
• Established Clinical Quality Professional, demonstrable CQA compliance experience and thorough understanding and application of GCP regulations, applicable country regulations and guidelines.
• Demonstrable knowledge and experience in audit principles, procedures and techniques.
• Deep understanding of risk management in clinical trials and the ability to apply a risk-based approach to both clinical studies and CQA activities.

Responsibilities

• Supports the implementation of the global quality strategy, as relevant to GCP across the clinical development business.
• Builds collaborative relationships with key internal and external stakeholders.
• Leads activities that support the implementation of the global quality management system.
• Supports the development of Quality and CQA team goals, objectives, and initiatives.
• Provides strategic and technical GCP compliance support to Jazz therapeutic area and clinical study teams.

Skills

GCP compliance

Audit principles

Risk management

Communication skills

Multitasking

Education

Bachelor's degree in science

Masters/PhD preferred

Tools

eQMS

eTMF

Job description

Jazz Pharmaceuticals, a global biopharma company, is seeking a Director of Clinical Quality Assurance to ensure GCP compliance across clinical development and trials. The role leads the CQA function and champions quality improvements.

You will drive risk-based quality activities, oversee CRO/vendor compliance, and collaborate with cross-functional teams to uphold standards and inspections readiness in regulated drug development in the United States.