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Head GxP Training System
Job ID194075BRPosition TitleHead GxP Training SystemDivisionCORPORATEBusiness UnitGROUP QACountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis International AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegularJob DescriptionThe Quality System Owner (“Business Process Owner”) responsible for developing, implementing and maintaining the Novartis wide GxP Training 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 GxP Training Quality System.
Responsible for definition and adequacy of the the Novartis Quality Standards for Qualification and Training of Personnel as outlined in the Quality Manual and the related Novartis wide Global Operating Procedures including their overall implementation strategy.
Responsible for definition and adequacy of the Novartis Quality Standards for Qualification and Training of Personnel as outlined in the Quality Manual and the related Novartis wide Global Operating Procedures including their overall implementation strategy.
Chair of the Novartis cross-functional Quality Training Council (QTC).
Establish and lead a global network of training experts to develop, implement, maintain and continually improve the Quality Systems training strategy and to share and implement best practices related to training.
Ensure that the training strategy is coordinated with the training initiatives of other business functions (eg: HR, HSE, IT, NTO, GDD, Corp Compliance, NBS )
Design, Develop and Implement Global Training processes and procedures to support Global QA System Business Process and agreed corporate GxP training programs.
Identify key training initiatives across the business units. Develop, coordinate and implement associated corporate training packages to ensure consistent level of expertise.
Establish, monitor, analyze and improve quality training metrics including compliance and efficiency.
Ensure GxP Training objectives and commitments are identified and considered in the overall Novartis Quality Plan.
Liaise with the Group and Functional Quality System Owners to evaluate training needs and ensure findings from audits and inspections are incorporated into GxP training programs/plans.
Represent Novartis (internally – Global Learning network and externally – government bodies) on all GxP training related matters.
Coordinate and proactively address regulatory trends concerning training requirements.
Oversee Novartis GxP Training infrastructure.
Act as Quality system owner (“Business Process Owner”) of the existing and future Novartis Corporate Learning Management System.
Representative in GxP Training Program Steering Committees (eq: UP4GROWTH) Operational - System/Process:
• Ensure alignment with Novartis Quality Manual.
• Ensure process for metric collections, analysis, and CAPA effectiveness for the Training Quality System across Novartis.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.
• Advanced knowledge of GxP practices and requirements, and the compliance and regulatory aspects of the pharmaceutical industry.
• Demonstrated experience managing a compliance training function, leading matrix teams, building and managing role-based curricula and leading instructor qualification programs is required.
• Expertise in Curricula Development and Adult Learning in necessary.
• Demonstrated leadership skills in implementing robust quality systems and setting global qualtiy 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 20 %).