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Job ID 194080BR Position Title Head GxP Document Management System Division CORPORATE Business Unit GROUP QA Country Switzerland Work Location Basel Company/Legal Entity Novartis International AG Functional Area Quality Job Type Full Time Employment Type Regular Job Description The Quality System Owner (“Business Process Owner”) responsible for developing, implementing and maintaining the Novartis wide GxP Document Management Quality System and its strategy. Govern and ensure adherence to internal Novartis Business requirements, standards and external regulations. This is through an active management, interface and collaboration with all levels of the organization including: NTO, Global Drug Development, NBS, Country Operations, Alcon and other functional organizations. Maintaining knowledge with current industry trends, Health Authority expectations and influence standards accordingly to incorporate and translate into business processes.
Develop the Vision and Strategy for the Novartis Document Management System.
Responsible to develop, implement and maintain system for Document Management Quality system as outlined in the Quality Manual and the related Novartis wide Global Operating Procedures including their overall implementation strategy.
Develop and implement processes and procedures to support Global QA System Business Process.
Develop, track, monitor, analyze and improve quality metrics to assure timely processing of Global QA System.
Manage Global QA Systems network for Document Control for Standard setting and best practice sharing network. Interface with Global and site Quality/TechOps Manufacturing, Regulatory Affairs, R&D and other business partners and process experts.
Responsible for alignment of Global QA Systems throughout Novartis through direct interface.
Direct interface with NBS IT Center of Excellence and responsible for Document Management System.
Establish and lead a global network of documentation system experts to develop, implement, maintain and continually and share best practices. Design, Develop and Implement Global Documentation processes and procedures to support Global QA System Business Process.
Establish, monitor, analyze and improve document management metrics including compliance and efficiency.
Liaise with the Group and Functional Quality System Owners to evaluate document management needs and ensure findings from audits and inspections are incorporated into document management system.
Oversee Novartis Document Management infrastructure.
Act as Quality system owner (“Business Process Owner”) of the existing and future Novartis Corporate Document Management System.
Representative in Novartis Document Management Steering Committees (eq: NBS IT Center of Excellence). Operational - System/Process:
• Ensure alignment with Novartis Quality Manual.
• Ensure Organization, Governance, Process, Procedures, People, Electronic System and Measurements are in place. Minimum requirements • Degree in Science, Business, Engineering or equivalent Discipline or appropriate combination of experience and education
• Excellent oral and written English communication skills.
• Second language is preferred
• Minimum 12 -15 years experience in regulated industry, 5 years in leadership role.
• Pharmaceutical, Chemical or Biological Operations.
• Direct experience working in a GMP/FDA, or other regulated environment.
• Experience in Quality Systems Management a plus.
• Advanced knowledge of GxP practices and requirements, and the compliance and regulatory aspects of the pharmaceutical industry.
• Demonstrated leadership skills in implementing robust quality systems and setting global quality standards in a regulated area
• Knowledge of external/internal quality standards and industry best practice a plus.
• Ability to travel globally as occasionally as needed and manage various scheduling requirements (up to 30 %).