Senior Quality Advisor – Biologics Regulatory Compliance
Elanco
August 13, 2026
On-site
Elwood, KS
Operations
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.
Minimum Qualifications:
- 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.
Preferred Qualifications:
- 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.
Additional Information:
- Locations: Elwood, KS; Indianapolis, IN; or Fort Dodge, IA. Travel: ~15–25%.
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.
Minimum Qualifications:
- 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.
Preferred Qualifications:
- 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.
Additional Information:
- Locations: Elwood, KS; Indianapolis, IN; or Fort Dodge, IA. Travel: ~15–25%.