Senior Quality Advisor Biologics Regulatory Compliance

Senior Quality Advisor Biologics Regulatory Compliance

The Senior Quality Advisor Biologics Regulatory Compliance plays a critical role in advancing quality, regulatory compliance, and commercialization efforts across Elanco's multi-site USDA Center for Veterinary Biologics (CVB) network. This strategic position partners with manufacturing sites and global quality organizations to strengthen compliance, support innovation, and drive continuous improvement while serving as a key regulatory liaison for USDA-CVB interactions.

Your Responsibilities:

• Develop and execute strategic quality initiatives that 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, representing the organization in interactions with USDA-CVB, managing regulatory submissions, and supporting technical compliance discussions.
• Partner with Manufacturing, Sterility Assurance, Global Technical Services, Central Quality, and other cross-functional teams to resolve quality and compliance challenges across the biologics network.
• Support the commercialization of new biologic products by participating on cross-functional project teams and providing quality oversight throughout the manufacturability review and technology transfer process.
• Identify opportunities to improve compliance and operational performance through benchmarking, data analysis, and continuous improvement initiatives while building business cases to influence senior leadership decisions.
• Coach and mentor colleagues on Root Cause Problem Solving methodologies, regulatory expectations, and technical writing to strengthen organizational capability.
• Prepare executive dashboards, reports, governance materials, and technical documentation to support effective decision-making and regulatory compliance.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor's degree in Biochemistry, Chemistry, Biology, Virology, or another science-related discipline required. Master's or PhD preferred.
• Experience: Minimum of 10 years of experience in the vaccine, biologics, or biotechnology industry with increasing responsibility in Quality, Manufacturing, or Regulatory Compliance.
• Top 2 Skills: Deep knowledge of biologics manufacturing and regulatory requirements (USDA 9 CFR, FDA, and/or EU GMP); and demonstrated ability to lead cross-functional quality and compliance initiatives while influencing stakeholders across the organization.

What Will Give You a Competitive Edge (preferred qualifications):

• Direct experience supporting USDA Center for Veterinary Biologics (CVB) licensure, regulatory submissions, and agency interactions.
• Experience leading commercialization and technology transfer activities for biologics or vaccine products in a regulated manufacturing environment.
• Expertise in sterility assurance, root cause problem solving, and continuous improvement methodologies, with demonstrated success coaching technical teams and driving sustainable quality improvements.

Additional Information:

• Location: Elwood, KS or Indianapolis, IN or Fort Dodge, IA
• Travel: Approximately 1525% travel to biologics manufacturing sites.
• This role partners closely with manufacturing, quality, regulatory, and technical organizations across multiple sites to support strategic initiatives, regulatory compliance, and commercialization activities.

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every qualification. At Elanco, we are committed to building a diverse and inclusive workplace. If you're excited about this role but your experience doesn't align perfectly with every qualification, we encourage you to apply. You may be the right candidate for this roleor another opportunity at Elanco.

Elanco Benefits and Perks:

We offer a comprehensive benefits package focused on supporting your financial, physical, and mental well-being while empowering you to pursue our purpose. Highlights include:

• Multiple relocation packages
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus opportunity
• Up to 6% 401(k) matching