Director, Quality Learning Management

Title:                Director Quality, Learning Management, Document Management 
Reports to:       VP, Global Head of Quality    
Location:         South San Francisco, CA 
 
Position Overview: 
This position will be responsible for leading strategy and implementation for company-wide GxP Learning and Development (processes, systems, governance of training curricula and reporting) and Document Management (processes, systems, templates, archiving, Quality Lead for document change processes, retention schedules).   
 
Responsibilities:
·       Develop vision and strategy for company-wide learning and development within the regulated functions (e.g., GMP, GCP, GLP, GDP) and develop strategic partnerships with additional learning management content owners (e.g., HR, Compliance, Commercial). 
·       Lead the development, implementation, and management of company-wide learning and development processes, systems, curricula and reporting to ensure optimal performance and compliance with laws and regulations in all relevant territories. 
·       Lead the development, implementation, and management of company-wide document management processes, systems, archiving and retention to ensure optimal performance and compliance with laws and regulations in all relevant territories. 
·       Oversee Global Procedural Document Control. 
·       Oversee development and design document templates for SOPs, TP, Specifications, Reports, and Protocols preferably in eCTD format.  
·       Interact with all departments to develop functional documentation and training requirements and implement processes and systems as appropriate.
·       Participate as a member of the Quality Leadership team fostering a compliant, efficient, effective Quality Management System supporting Our client product development and commercial objectives.
·       Represent training and document control functions and systems in health authority inspections and internal audits.
·       Build and lead a team of engaged quality professionals. 
 
 
 
 
 
 
Requirements:
Education and Experience:

·       Bachelor’s degree in a scientific discipline, with an advanced degree, preferred. 
·       10+ years of experience in the pharmaceutical industry; with 5+ years of experience directing Quality Management functions and staff including; leading document management, learning & development and recruiting, managing and developing high-performance teams.
·       Experience managing electronic document management systems and learning management systems is required.  Experience managing within electronic QMS and with computer system validation strongly desired.

Competencies and Attributes:

·       Demonstrated leadership ability to drive results that are needed to achieve the company objectives in accord with the Our client core cultural values of courageous, creative and selfless.
  • Well-organized and detailed oriented professional, with strong verbal and written communication skills.
  • Good computer skills with experience and working knowledge of MS Office (Word and Excel, Access, Adobe Acrobat professional).
  • Strong collaboration skills with emphasis on Project Management and Process Excellence
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