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Apply to JobJob ID241498BRPosition TitleSenior Process Governance ManagerJob DescriptionThe successful candidate will develop and implement strategies across Novartis Divisions, in line with operational strategy, to maximize efficiency in the processes used to review, approve and track process changes and procedural document modifications within CMO&PS, and collaborate with business leads to ensure assigned processes are compliant with worldwide regulatory requirements and Novartis group policies and that procedural documents are of a high quality.



Major accountabilities include:

• Drive simplification and improvements in efficiency in the processes used to review, approve and track process changes and procedural document modifications within CMO&PS; lead CMO&PS projects related to the process governance and represent CMO&PS on cross functional projects; implement operational strategy, including outsourcing strategies, as agreed with the Head of Process Governance; drive compliance to CMO&PS standards with regards to process change management and procedural document quality through;

• Develop and implement training and communication strategies on process governance standards and change management processes;

• Develop and implement appropriate Key Performance Indicators (KPIs) to measure compliance to process governance standards and change management processes; review process change proposals from Business Leads prior to presentation to Process Change Committee and, post approval from the committee, review project plans, track progress and ensure appropriate effectiveness checks are in place for post implementation; work with assigned business lead(s) to implement complex process changes in procedural documents by: identifying stakeholders - chairing workshops and review meetings - documenting outcomes - and presenting the documents to the appropriate approval body; perform quality checks on procedural documents prepared by other associates to verify that they meet quality standards before presentation to the Process Review Board; act as a subject matter expert on process governance and change management during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions; train and mentor Chief Medical Office & Patient Safety (CMO&PS) associates on process governance standards and change management processes as well as associates from other Global Line Functions as necessary; collaborate with other Global Line Functions across Novartis Divisions and Third Parties to meet joint accountabilities; represent Novartis externally as a subject matter expert on process governance standards and change management processes.

Minimum requirementsEducation:

PharmD, MSc degree in life sciences or equivalent.



Language:

Fluency in English. Knowledge of other languages desirable.



Ideal background:

• Minimum 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance

• Leadership and (matrix) management experience.

• Ability to lead and deliver cross-functional initiatives in a matrix environment.

• Strong organizational and project management skills.

• Strong negotiation and communication skills and ability to operate effectively in an international, matrix environment

• Ability to lead global and cross-functional work groups; deal and interact with a wide variety of people at all levels. Excellent document writing skills

• Experience of working with and supporting a team; ability to coach and mentorDivisionGlobal Drug DevelopmentBusiness UnitCMO & PATIENT SAFETY GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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