171 - CMC Data Integrity Program Lead > Joboolo BE :
Société : ProductLife Group Lieu : Braine-l'Alleud Wallonia Site source : Talent BE
Strong understanding of regulatory requirements in the pharma industry Group 13 Skills Deep, sustained, and current knowledge in and experience with current CMC DataIntegrity requirementsProficient in CMC knowledge and in overall pharmaceutical businessFamiliar with new technologies that are part of the digital transformation initiatives and the respective challenges and risks they pose,A good and thorough understanding of current CMC regulatory requirements and expectations (e.g., US, Europe, Japan, China) and an ability to interpret current regulations and requirements is essentialExperience in managing GMP Inspections across geographies, including inspector facing experienceExcellent verbal and written communication and interpersonal skillsMust be fluently speaking EnglishMust have excellent presentation skills and the ability to present content in an influential / compelling manner in front of senior managementWorks entirely independently with minimal supervision yet is a team player with and in a proactive approachAbility to present complex projects and issues to senior management in a clear, succinct, coherent mannerNegotiation skills and a proven ability to influence senior leaders and others within a global matrix organizationMust have the ability to adapt the delivery of message (i.e., strategy, process, training) to any audience, with an engaging, collaborative, and influential mannerProven analytical and investigation skills to understand global, complex Compliance and Regulatory issuesAble to cope with stressful situations and drive issue resolution and decisionsExcellent planning and organizational skills with the ability to prioritize according to company priorities, Compliance and Patient Safety riskAble to identify and manage critical issues and escalate to executive management, if requiredAbility to build partnerships internally and externallyManagement and facilitation of Transversal and Process improvement projectInspirational leader with the ability to motivate, develop and support her/his team ProductLifeGroup Braine-l'AlleudWallonia
