Associate Director / Director of Clinical QA

6 Month Contract - Extension and Conversion Potential

Responsibilities:

• Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
• Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
• Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
• Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, root cause analysis, CAPA planning and management.
• Escalate identified issues to QA Management as needed.
• Enable other assigned GCP or GXP related tasks, as appropriate.

Required Skills, Experience and Education:

• Bachelor’s degree in scientific or technical discipline.
• A minimum of 12 years of experience in GCP Quality in the pharmaceutical or biotechnology industry
• 12 years in the following areas: audit / audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.
• Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (FDA, EMA) regarding applicable drug development regulations.
• Effective communication (verbal and written).
• Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.
• Ability to critically evaluate and troubleshoot complex problems with diligence.
• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).