Rudolph A. Kircher

About Rudolph A. Kircher

Accomplished professional in the pharmaceutical industry with a proven track record of successful performance demonstrated through holding positions of increasing responsibility and influence in GxP environments. Held multiple, matrix-management and line-management roles in Quality Assurance, Technical Research and Development, Quality Control, and Analytical Research and Development in dynamic work environments within traditional and matrix organizational structures. Leadership, management, and organizational skills established through leading local and global teams focused on long and mid-term strategic planning, resource management, personnel training, policy and procedure implementation, and process improvement.Strong collaborative mindset demonstrated through effective collaboration with cross-functional internal and external business partners on strategic, operational, and technical initiatives.

Experience

1. Senior Quality Manager, Global Drug Development

   Novartis

   Jan 2014 — Present

   Ensure that Investigational Medicinal Products (IMPs) are released for clinical use in accordance with regulatory filings and international/local regulations by evaluating compliance against the study protocol, Investigational New Drug (IND) submission, and technical release documentation. Ensure that all aspects of IMP handling, manufacturing, packaging, labeling, storage and distribution comply with regulatory and legislative requirements. Decide on clinical study drug final release status. Lead or participate in global and local cross-functional project teams to support portfolio initiatives. Initiate, review, and approve quality investigations. Ensure quality oversight of External Service Providers. Compile key quality indicator (KQI) data, monitor KQI performance, and communicate KQI performance results to key stakeholders. Liaise with External Service Providers, Regulatory Affairs, Drug Supply Management, and Clinical Trial Teams in order to provide quality oversight and establish good working relationships.

Education

• University of California, Davis

  Certification Program, Geographic Information Systems (GIS)

• Villanova University

  Certification Program, Lean Six Sigma

• Cornell University

  Certification Program, Project Management

• Kean University

  Bachelor's Degree, Chemistry

Skills

• Pharmaceutical Industry
• Quality Operations
• Technology Transfer
• Lc-Ms
• Quality Assurance
• Gmp
• Nmr
• Validation
• Analytical Chemistry
• Training Management
• Hplc