Senior Quality Advisor – Biologics Regulatory Compliance

Elanco; Elwood (KS); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Relocation packages

Parental leave (8 weeks)

Employee Resource Groups

Annual bonus opportunity

401(k) matching (up to 6%)

Job summary

Elanco, a global leader in animal health, seeks a Senior Quality Advisor to strengthen regulatory compliance across the biologics network. You will lead strategic quality initiatives, interact with USDA CVB, and collaborate with manufacturing, sterility, and global tech services to drive quality improvements.

Ideal candidates have 10+ years in vaccines/biologics quality or regulatory compliance and deep knowledge of USDA/FDA/EU GMP regulations.

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Biology, Virology, or another science-related discipline required. Master's or PhD preferred.
• Minimum of 10 years of experience in the vaccine, biologics, or biotechnology industry 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); demonstrated ability to lead cross-functional quality and compliance initiatives.

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.

Skills

Biologics regulatory knowledge

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in science

MS or PhD preferred

Job description

At Elanco (NYSE: ELAN) - it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better - join our team today!

Your Role: Senior Quality Advisor - Biologics Regulatory Compliance

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 15-25% 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 role - or another opportunity at Elanco.

Elanco Benefits and Perks:

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

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.