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Hiring Company: BioPhase Solutions

Job Code: SD-846

Location: San Diego, CA

Description: BioPhase Solutions specializes in recruiting top talented professionals for San Diego’s Scientific community. We are currently looking for a Sr. Manager – Quality Systems to work for a leading San Diego biotechnology company.

Sr. Manager – Quality Systems

Responsible for performing and managing quality-related tasks to assure compliance with regulations and standards set forth by regulatory and accrediting agencies for both the pharmaceutical and diagnostic divisions of the company.

• Participates in and/or leads the development, implementation, and maintenance of the company’s quality management system
  
• Assists management in the conceptualization of the strategic quality direction, quality plan elements, and the quality manual
  
• Develops, reviews and approves documents to ensure compliance with established procedures and regulations (e.g., change management, master and executed batch record review and release, deviations, specifications, reports, CAPA and SOPs)
  
• Oversees the internal and external audit/assessment programs to ensure compliance to written procedures and regulatory requirements. Provides leadership and guidance to personnel who are involved in the audit process
  
• May participate in the management of the deviation, CAPA and training programs for cGMP compliance
  
• Provides quality assurance oversight and support of contract manufacturing organizations and suppliers to ensure compliance with established procedures and regulations
  
• Develops effective partnerships with internal staff and external organizations to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvement
  
• Tracks, trends and evaluates data and provides detailed reports to management for evaluation
  
• Represents Quality Systems on new product development teams
  
• Provides support to quality management in the preparation for, conduct of, and follow-up activities associated with site visits from clients and regulatory/accrediting agencies
  
• Participates in and/or facilitates organizational project teams.

Link for more information: http://www.biophaseinc.com