One of our client is looking for a CMC Data Integrity Program Lead W/M to join their team.

Group 10
Responsibilities

Drive the development, implementation, and maintenance of the S&TS Data Integrity framework such that it:

  • complies with applicable and upcoming regulations and regulator’s expectations across GMP
  • enables continuous improvement including innovation in design and approach,
  • focuses adding value and maximizing agility,
  • proactively provides emphasis on business efficiency for people, processes, and systems,
  • aims for constant inspection-readiness state

 

3 main aspects of the missions :

 

  • CMC integrity Network (GMP, GSP)
  • GMP, GSP Data Integrity
  • People and Team management

 

 

Group 11
Education

  • Master’s Degree in CMC and Data Integrity
  • Proven experience in leadership role, with a focus on CMC. Strong understanding of regulatory requirements in the pharma industry

 

Group 13
Skills

  • Deep, sustained, and current knowledge in and experience with current CMC Data Integrity requirements
  • Proficient in CMC knowledge and in overall pharmaceutical business
  • Familiar 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 essential
  • Experience in managing GMP Inspections across geographies, including inspector facing experience
  • Excellent verbal and written communication and interpersonal skills
  • Must be fluently speaking English
  • Must have excellent presentation skills and the ability to present content in an influential / compelling manner in front of senior management
  • Works entirely independently with minimal supervision yet is a team player with and in a proactive approach
  • Ability to present complex projects and issues to senior management in a clear, succinct, coherent manner
  • Negotiation skills and a proven ability to influence senior leaders and others within a global matrix organization
  • Must have the ability to adapt the delivery of message (i.e., strategy, process, training) to any audience, with an engaging, collaborative, and influential manner
  • Proven analytical and investigation skills to understand global, complex Compliance and Regulatory issues
  • Able to cope with stressful situations and drive issue resolution and decisions
  • Excellent planning and organizational skills with the ability to prioritize according to company priorities, Compliance and Patient Safety risk
  • Able to identify and manage critical issues and escalate to executive management, if required
  • Ability to build partnerships internally and externally
  • Management and facilitation of Transversal and Process improvement project
  • Inspirational leader with the ability to motivate, develop and support her/his team

171 - CMC Data Integrity Program Lead