Associate Director / Director, Quality Systems and Compliance QA

San Diego, CA     ·     Full time

This position is responsible for developing and maintaining quality systems that support GxP compliance in a clinical development environment.  This includes developing and managing the document management functions, training systems, supplier management, metrics reporting, CAPA systems, and Quality Management Review.  In collaboration with cross-functional team members, ensure that Quality Systems are implemented in a phase appropriate manner meeting Regulatory and Quality requirements. 

Essential Duties And Responsibilities 

• Develop and maintain a GMP compliant document control function with appropriate processes, procedures, and practices. Maintain/Manage Electronic Document Management System for Document Management

• Implement/manage the corporate Training System and training records. Work with department heads to develop training curriculums for all GxP personnel
• Develop and implement supplier management program. Establish an approved supplier list. Establish Quality Agreements with critical suppliers
• Develop and implement internal and external audit program. In that, establish an annual schedule for internal and external audits. Ensure audit schedule is executed as planned and conduct audits as appropriate. Write audit reports within 30 days from the audit date. Follow-up on audit observations until adequate closure
• Perform trending and analysis as required and provide metrics to quality management as requested in preparation for Quality Management Review
• Establish and maintain a work environment that fosters open communication, collaboration, integration, and teamwork
• Stay abreast of changes in applicable regulations, directive and guidelines and determine its impact on company programs
• Complete other duties and tasks as required
• 10%-20% Travel

Qualifications

• Knowledge of regulations and standards affecting Pharmaceuticals, and Biologics.

• Experience with GMP/GCP/ICH standards and regulatory guidance documents
• Experience in auditing and writing formal audit reports
• Excellent verbal and written communication skills
• Certified Quality Auditor (CQA) certification preferred

Education And / Or Experience 

• Bachelor’s degree in health science or medical field or equivalent
• 8+ years of experience in the pharmaceutical or biotechnology industry, 4+ years of experience in conducting internal and external audits
• Experience managing the QA function a plus

To apply: Please email your resume to careers@aspenneuro.com

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