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!

This position is accountable for Quality oversight and lifecycle management of assigned Elanco finished drug products; API; contract manufacturing organizations (CMO’s) and suppliers ensuring that Elanco products meet all legal and internal requirements. This role will actively collaborate with quality, regulatory, technical services, operations, and supply chain counterparts to support quality document reviews/approvals and batch release.

Your Responsibilities:

• Provide Quality Oversight & release activities for Elanco Externally Manufactured Medicinal and Non-Medicinal products. This may include but not limited to the following: parenteral, solid oral dose, non-sterile liquid, premix, API, and EPA/parasiticide products.
• Manage and support positive CMOs / Suppliers selection and on-boarding of CMO’s / Suppliers with assurance of compliance with the regulatory, cGMP requirements and the Elanco Quality Manual / Directives
• Manage and support positive CMOs / Suppliers relationships. Facilitates open communication and cooperation with high integrity.
• Manage and support the resolution of issues at CMOs/Suppliers, escalates issues appropriately and timely and drive corresponding continuous improvement initiatives.
• Guide internal functions within Elanco and external partners (e.g training, issue resolution, interpretation of standards, inspection readiness, etc.)
• Drive the utilization of Risk Management principles for CMOs/Suppliers oversight and monitor CMOs / Suppliers QA performance metrics and reports.
• Ensure Quality Plans are established and executed appropriately for assigned API CMOs/Suppliers while providing support for new API launches/acquisitions to ensure compliant systems and procedures are in place to manage new products.
• Partner with technical services & manufacturing operations to assure that CMO deviations are compliant, root cause and CAPA plans are appropriate and implemented in a timely manner.
• Develop and execute approved quality procedures (SOP’s) applicable to the EEM organization and quality function: product documentation review, product release, deviation review/approval, CAPA effectiveness monitoring, change management, laboratory investigation review/approval, complaint investigation review/approval.
• Leverage subject matter expertise in the review and approval of technical documents supporting the validated state of commercial product, including process validation reports, manufacturing technical documents, stability reports and process flow diagrams. Ensure development of continuous improvement strategies if applicable.
• Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.

What You Need to Succeed (Minimum Qualification)

• University Degree in relevant field of study and or equivalent years of experience in a GMP environment
• Minimum of 4 years' experience
• Demonstrated cGxP experience, specifically leading complex investigations; deviation / CAPA management; change leadership and risk management with a strong understanding of regulatory requirements (cGMP, FDA, EMEA).
• Demonstrated problem solving, quality risk management, project management and decision-making skills.
• Continuous Improvement (OE / Lean) mindset – can comfortably quantify & articulate the impact of OE projects and their impact (monetary, headcount, efficiency) to an organization.

Additional Preferences:

• Bachelor’s degree in chemistry, pharmacy, engineering or other technical areas of study
• 7+ years' experience
• Demonstrated technical subject matter expert (SME) in the pharmaceutical industry, specifically supporting the production of finished drug product; API; pre-mixes, Solid Oral Dose, Injectables.
• Effective influencing & collaboration abilities – working across various cultures, languages, work styles and levels within a global organization.
• Multi-lingual skills highly valued.

Additional Information:

• Expected Travel: Up to 20%

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:

Relocation packages

· Two week shut downs (mid-summer and year-end) in the US (in addition to PTO)

· 10-week parental leave

· 9 Employee Resource Groups

· Annual bonus offering

· Flexible work arrangements

· Up to 6% 401K matching

· Dependent and childcare support

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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