Dian Feuerhelm

About Dian Feuerhelm

I have extensive experience in building and leading global Quality and Regulatory organizations in the pharmaceutical industry. Senior Chemistry, Manufacturing & Controls (CMC) and Non-clinical professional with over 30 years experience in submission management at all stages of a product\'s lifecycle (IND/CTA, BLA/NDA, post-approval), Quality Control, inspection management (GLP), Pharma Quality Systems, GMP training, process and computer validation, and GMP facility documentation. I have built and established several successful organizations and business systems. I have managed the quality and regulatory aspects for products through their lifecycle - from bench, to market, through commercialization, to decommissioning. I have a strong skill set in leadership, talent development, decision making, negotiation, problem solving, and influence management.

Experience

1. Global Head, Regulatory Submission and Information Management

   Roche

   Jan 2015 — Present · Basel, CH

   Lead a global operations organization with staff in Switzerland, California and Germany. The organization provides end-to-end submission operations and tracking from planning through to archiving. Global Leadership:• Recruited, hired and developed a strong diverse leadership team. • Recognized leader in developing strategies that drive alignment across the Roche network.• Improved operations across the regulatory organization by creating robust global processes, tools and practices.• Viewed as a strong network leader, partnering with peers and key stakeholders.Decision Making:• Demonstrated strong decision making skills. Extensive knowledge and experience enables understanding of the broader context of decisions and their impact ensuring a successful outcome.• Makes good decisions in ambiguous situations and follows through with clear direction to organization• Develop staff and push decision making to the lowest level.Strategic and Financial:• Developed the organization’s mission, strategy, budget and goals, continually adjusting to match an evolving long-term strategy. • Strong, active and vocal member of the Leadership team providing feedback and influencing the organization’s direction.• Successfully manage the annual operating budget across multiple sites.

Education

• Linfield University

  BA

Skills

• Commercialization
• Cgmp
• Manufacturing
• Biotechnology
• Pharmaceutical Industry
• Fda
• Validation
• Clinical Trials
• Clinical Research
• Capa
• Drug Development
• Biopharmaceuticals
• Glp
• Quality System
• Technology Transfer
• Document Management
• Gmp
• Computer System Validation
• Chemistry
• Change Control
• Regulatory Affairs
• Software Documentation