Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.
In collaboration with the Elanco Affiliate organization and Order to Cash Operations, the Quality Manager leads the implementation, maintenance and operations of the Quality system for the Elanco Solutions Center, and escalates any quality matters relating to the appropriate affiliate and ESC management, Regional Quality Director or Corporate management when needed.The Quality Manager will provide independent quality oversight ESC GxP activities and decisions in collaboration with the Affiliate Quality organization and ensure specific Affiliate requirements are met. The Quality Manager will represent the ESC Quality organization within ESC, ensure active communication with the Affiliate Quality Organization and maintain a strong working relationship inside and outside of ESC.
Manage the Quality Systems in place to support activities managed through ESC comply with the applicable GxP, other applicable company quality standards and local regulations.
Manage Quality Management activities within the ERP (SAP) system associated to Customers and Material Master (QM Power user & QM Data Steward activities)
Accountable for Quality Management activities including but not limited to Recall activities, Product Complaint management, Customer License management, Inventory management (expiration, returns, adjustments)
Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.
Ensure Audit preparation and observation completion
Raise Notifications to Management, if and when required
Accountable for the completion & accuracy of operational quality tasks, including but not limited to deviations management, change control management, quality document management and maintenance of the Quality Plan, Quality Agreements
Monitor, trend, interpret & report on Quality metrics
Help and give guidance on resolution of Quality issues, as applicable
Develop local talent to sustain competitiveness; this includes coaching employees; developing and implementing impactful training plans; managing & evaluating performance against expectations / scorecard.
Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
Perform any other duties or serve in such other capacity as may be determined by Company management.
Bachelor degree in pharmacy, science, engineering, or related field and / or relevant experience
Demonstrated leadership / influencing skills in a cGxP environment; preferably within a Quality role. Typically over 3-5 years. Examples of cGxP environments could include manufacturing, warehouse management, affiliate quality.
Ability to both lead and support; and a track record of business partnering with internal stakeholders
Effective communications (written/verbal), presentation and facilitation skills
Interpersonal savvy, with the capacity to build strong relationships at a senior level
Demonstrated analytical & investigational skills
Effective organizational and planning skills; managing near term priorities & strategic aspirations
Experienced in both Microsoft Office and SAP
Fluent in English (written & verbal)
Inventory management and QM data knowledge highly regarded.