Senior Quality Advisor – Biologics Regulatory Compliance

Senior Quality Advisor – Biologics Regulatory Compliance Responsibilities:

• Develop and execute strategic quality initiatives to strengthen regulatory compliance, improve quality performance, and support the Biologics Network Quality strategy.
• Serve as an Alternate Liaison for Elanco’s USDA Establishment; represent the organization with USDA-CVB, manage regulatory submissions, and support technical compliance discussions.
• Partner with Manufacturing, Sterility Assurance, Global Technical Services, Central Quality, and other teams to resolve quality and compliance challenges across the biologics network.
• Support commercialization of new biologic products by participating in cross-functional project teams and providing quality oversight during manufacturability review and technology transfer.
• Identify improvements to compliance and operational performance via benchmarking, data analysis, and continuous improvement; build business cases for senior leadership.
• Coach/mentor colleagues on Root Cause Problem Solving, regulatory expectations, and technical writing.
• Prepare executive dashboards, reports, governance materials, and technical documentation.

• Bachelor’s degree in Biochemistry, Chemistry, Biology, Virology, or related science;
  Master’s or PhD preferred.
• 10+ years in vaccine/biologics/biotechnology with increasing responsibility in Quality, Manufacturing, or Regulatory Compliance.
• Deep knowledge of biologics manufacturing and regulatory requirements (USDA 9 CFR, FDA, and/or EU GMP); ability to lead cross-functional quality/compliance initiatives.

• Experience supporting USDA CVB licensure, regulatory submissions, and agency interactions.
• Experience leading commercialization and technology transfer in regulated manufacturing.
• Expertise in sterility assurance, root cause problem solving, and continuous improvement; success coaching technical teams.

• Locations:
  Elwood, KS;
  Indianapolis, IN; or Fort Dodge, IA. Travel: ~15–25%.