Title: Director Quality, Learning Management, Document Management
Reports to: VP, Global Head of Quality
Location: South San Francisco, CA
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).
· 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.
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