Senior Quality Advisor – Biologics Regulatory Compliance

Elanco in; Elwood (KS); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee resource groups

Annual bonus

401(k) matching

Job summary

Elanco is seeking a Senior Quality Advisor – Biologics Regulatory Compliance to lead regulatory and quality initiatives across the CVB network. This role partners with manufacturing sites and global quality teams to strengthen compliance, support innovation, and drive continuous improvement.

Location options include Elwood, KS; Indianapolis, IN; Fort Dodge, IA. Travel 15–25% is expected as you engage with site leaders and regulatory agencies to advance submissions and licensure.

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Biology, Virology or related science; Master's/PhD preferred.
• 10+ years in vaccine/biologics industry with increasing responsibility in Quality, Manufacturing or Regulatory Compliance.
• Deep knowledge of regulatory requirements (USDA 9 CFR, FDA, EU GMP).

Responsibilities

• Develop and execute strategic quality initiatives to strengthen regulatory compliance.
• Alternate Liaison for USDA Establishment; manage regulatory submissions and technical compliance discussions.
• Collaborate with Manufacturing, Sterility Assurance, Global Technical Services and other teams to resolve quality and compliance challenges.
• Support commercialization of new biologic products through cross-functional project teams and tech transfer oversight.
• Identify opportunities to improve compliance and operational performance through benchmarking and data analysis.

Skills

Biologics manufacturing

Regulatory compliance

Cross-functional leadership

Education

Bachelor's degree in Biochemistry/ Biology/ Virology

Job description

Senior Quality Advisor – Biologics Regulatory Compliance (Project Management)

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

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 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.

Elanco Benefits and Perks:

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

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