Senior Quality Advisor – Biologics Regulatory Compliance
Elanco
August 13, 2026
On-site
Indianapolis, IN
Operations
Senior Quality Advisor – Biologics Regulatory Compliance
Responsibilities:
- Develop and execute strategic quality initiatives to strengthen regulatory compliance, improve quality performance, and support the long-term Biologics Network Quality strategy.
- Serve as an Alternate Liaison for Elanco’s USDA Establishment; manage interactions with USDA-CVB, including regulatory submissions and 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 via cross-functional project teams and quality oversight during manufacturability review and technology transfer.
- Improve compliance and operational performance through benchmarking, data analysis, continuous improvement, and business cases for senior leadership.
- Coach and mentor colleagues on Root Cause Problem Solving, regulatory expectations, and technical writing.
- Prepare executive dashboards, reports, governance materials, and technical documentation.
Qualifications (minimum):
- Bachelor’s degree in Biochemistry, Chemistry, Biology, Virology, or related field (Master’s/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:
- Experience with USDA CVB licensure, regulatory submissions, and agency interactions.
- Leadership in commercialization and technology transfer for regulated biologics/vaccines.
- Expertise in sterility assurance, root cause problem solving, and continuous improvement; track record coaching teams.
Benefits (if offered): Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus opportunity; up to 6% 401(k) matching.
Responsibilities:
- Develop and execute strategic quality initiatives to strengthen regulatory compliance, improve quality performance, and support the long-term Biologics Network Quality strategy.
- Serve as an Alternate Liaison for Elanco’s USDA Establishment; manage interactions with USDA-CVB, including regulatory submissions and 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 via cross-functional project teams and quality oversight during manufacturability review and technology transfer.
- Improve compliance and operational performance through benchmarking, data analysis, continuous improvement, and business cases for senior leadership.
- Coach and mentor colleagues on Root Cause Problem Solving, regulatory expectations, and technical writing.
- Prepare executive dashboards, reports, governance materials, and technical documentation.
Qualifications (minimum):
- Bachelor’s degree in Biochemistry, Chemistry, Biology, Virology, or related field (Master’s/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:
- Experience with USDA CVB licensure, regulatory submissions, and agency interactions.
- Leadership in commercialization and technology transfer for regulated biologics/vaccines.
- Expertise in sterility assurance, root cause problem solving, and continuous improvement; track record coaching teams.
Benefits (if offered): Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus opportunity; up to 6% 401(k) matching.