Senior Associate, Quality Assurance - External Manufacturing (Engineering)
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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
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 Associate, Quality Assurance - External Manufacturing
As a Senior Associate, Quality Assurance for External Manufacturing, you will be part of the Elanco Global Quality team, ensuring the quality and compliance of finished drug products manufactured by contract manufacturing organizations (CMOs) and suppliers. In this role, you'll be responsible for overseeing product release, maintaining quality systems, and driving compliance with regulatory and internal standards.
Your Responsibilities:
Lead quality oversight and product release for externally manufactured products including parenterals, solid oral dose forms, non-sterile liquids, premix, APIs, and parasiticides, ensuring all batches meet internal standards, cGMP regulations, and global regulatory requirements prior to distribution.
Oversee the qualification, onboarding, and lifecycle management of CMOs and suppliers by facilitating cross-functional assessments, executing Quality Plans, and ensuring ongoing compliance through audits, performance reviews, and risk-based monitoring of quality metrics.
Drive resolution of quality issues at CMOs and suppliers through active investigation support, root cause analysis, and timely implementation of effective CAPAs; escalate high-impact issues appropriately while fostering a collaborative and accountable relationship with partners.
Review and approve critical quality and technical documentation such as deviations, change controls, process validation protocols and reports, laboratory investigations, and manufacturing technical documents to ensure the validated state of commercial products is maintained throughout their lifecycle.
Act as a key quality liaison across internal and external stakeholders to support inspection readiness, training initiatives, interpretation of quality standards, and integration of newly acquired or launched products into compliant quality systems and procedures.
What You Need to Succeed (minimum qualifications):
Education: Bachelor's Degree in Chemistry, Pharmacy, Engineering, or a related technical discipline.
Required Experience: A minimum of 5 years in pharmaceutical quality assurance, including experience with sterile and non-sterile drug product manufacturing.
Top 2 Skills: Expertise in deviation/CAPA management and strong cross-functional collaboration skills.
What Will Give You a Competitive Edge (preferred qualifications):
Demonstrated experience leading complex quality investigations and continuous improvement projects (Lean/OE).
Working knowledge of FDA and Americas regulatory requirements, including inspection management.
Proven ability to influence and collaborate across cultures and global teams.
Experience supporting product launches or acquisitions with quality systems implementation.
Multilingual capabilities, especially in languages relevant to global manufacturing sites.
Additional Information:
Travel: Up to 20% annually.
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K 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
