Bachelor's degree or PhD in Life Sciences, Pharmacy or Medicines.
Demonstrated experience of success leading an organization or project of high impact
Fluency in English (oral and written); knowledge of other languages spoken in the respective region is a plus
8 to12 years of Quality Assurance experience and involvement in regulated activities; broad understanding of global expectations of Health Authorities in Good manufacturing/clinical practices
Knowledge of Quality Systems and Health Authority regulations (Sterile and non-sterile products)
Deep understanding of Change Control System, Complaints, Deviation and Country Product Release, in particular for commercial products. Regulatory Affairs knowledge is also required.
Ability to work independently on complex problems/issues and determine acceptable solutions and approaches.
Demonstrated ability to build trusting relationships with senior management and other business stakeholders.
Excellent communication, negotiation, consulting/facilitation, and interpersonal skills.
Candidate should have Lean Six Sigma certification such as Green Belt, Black Belt etc.
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