Senior Manager Clinical Development Quality - Biosimilar Programs

Major Accountabilities:

• Ensure the implementation of clinical quality standards in Biosimilar part of GCD business under responsibility and contribute in setting up, improving and maintaining One Sandoz Clinical Management System in alignment with Sandoz Policies and procedures and international regulations and guidelines
• Regularly monitors the operational compliance in clinical activities and clinical studies in Biosimilars under responsibility, by executing GCP self-inspections and QA site visits (internal or external clinical sites or ESPs), as needed.
• Acts as CQA in revisions of Biosimilar or Sandoz harmonized SOPs as needed.
• Identify lessons learned relevant for Biosimilar clinical programs, and ensure knowledge sharing in appropriate forums and formats. Ensure and lead proactive continuous improvement initiatives.
• Provides support for audit and inspection readiness to Biosimilar clinical programs.
• Ensures escalation of quality issues/ quality alerts as appropriate to Senior Management.
• Ensures appropriate annual program audit planning, so that ESPs and their critical subcontractors as well as investigator sites used in biosimilar clinical programs are in time audited, qualified or requalified, and audits are planned according to identified risk areas. Identify key risk areas for inclusion into internal audit and self-inspection programs.
  

Minimum Requirements: Minimum 15 Plus experience

Work Experience

• People Challenges.
• Managing Crises.
• Cross Cultural Experience.
• Collaborating across boundaries.
• Operations Management and Execution.
• Project Management.
  

Skills

• Drug Development.
• Program Development.
• Program Management.
• Project Management.
• R&D.
• Team Management.
  

Languages

• English.