Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.
The Quality Assurance Manager provides daily compliance oversight and guidance to Quality Assurance and manufacturing personnel. Quality Assurance responsibilities include managing non-conformance investigations, change controls, validations, batch disposition, and qualification activities against regulatory guidelines and Elanco quality standards. The QA manager, working with the Senior Director of Quality, will aid in planning and managing long term site quality goals.
- Provide a daily presence in the manufacturing environment to provide compliance guidance and oversight for to process teams including quality assurance, manufacturing supervisors/operations, engineering/maintenance and technical services.
- Consistently provide leadership, feedback, and coaching to Quality Assurance colleagues through routine performance evaluations and responsibility oversight.
- Actively contribute to process teams by providing compliance guidance and oversight and participating in manufacturing gembas and internal audits.
- Oversee disposition of raw materials, semi-finished (antigen), and finished materials (vaccine).
- Responsible for quality systems including; document control, batch record review and release, distribution quality oversight, sample management, etc.
- Provides guidance to ensure compliance with Elanco quality systems and regulatory compliance
- Drives continuous improvement of all quality systems and processes
- Assist with or communicate directly through verbal and/or in writing with regulatory authorities, as required
- Participates in and provide direct guidance during both internal and external audits and inspections
- Assist partners with writing change controls, deviations, and performing investigations
- Responsible for the oversight of site Quality Management systems.
- Aid in preparing and managing annual operating and capital improvement budgets.
- Provides monthly metrics for site Quality Lead Team and Global network metric review meetings.
- Communicates product quality problems, recommends corrective action (s), and specifies follow-up procedures.
- Leads and/or participates in both quality and partner continuous and capital projects
- Performs other duties as required
- Bachelors degree (science or engineering degree preferred)
- Must have a minimum of 5 years of experience in Quality or Manufacturing role
- Demonstrate strong oral, written, and interpersonal skills
- Demonstrated ability to lead and work within a team
- Demonstrated consistent decision making and ability to act according to a strategic plan
- Root cause analysis and troubleshooting skills
- Proficiency with applicable computer systems
- Demonstrated attention to detail and ability to work within quality systems
- Technical writing skills
- A minimum of 2 years of management experience
- Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office
- Knowledge of or experience in Lean, Six-Sigma or Operational Excellence
- Experience working in a regulated aseptic manufacturing environment
- Excellent communication, organization, and leadership skills
- Strong interpersonal and team building skills; ability to lead and influence in a team environment
- < 10% travel may be required
- Relocation benefits included
- Personal Protective Equipment may be required when working in certain areas
- Biosecurity environment within a manufacturing site
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