The Quality Assurance Manager manages the Quality Assurance department and personnel. The QA Manager provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change controls, procedure/manufacturing batch record changes, validations, batch disposition, and qualification activities. The QA Manager ensures product and site compliance with USDA and other country regulations and Elanco Quality Standards. The QA Manager is essential for maintaining compliance (internal and external) and providing support during internal/external inspections.
Functions, Duties, Tasks:
- Leads, coaches, develops, and evaluates the performance and behavior of Quality Assurance (QA); Reviews and manages employee training plans, ensuring employees are competent to perform duties.
- Active member of the process team in Manufacturing to support daily operations
- Provide routine and non-routine quality guidance for the process team functional area, 24/7
- Review batch disposition of incoming materials, semi-finished (antigen), and finished materials (vaccine)
- Serves as a site mentor and coach for all personnel on quality matters
- Responsible for quality systems including; document control, batch record review and release, distribution quality oversight, sample management, etc.
- Provides guidance in all areas to ensure compliance with Elanco quality systems and USDA compliance
- Drives continuous improvement of all quality systems and processes
- May become an alternant USDA liaison for the site who provides primary support during internal/external regulatory inspections
- Communicates verbally and in writing with Regulatory Authorities as required
- Participates in internal and external inspections
- Effectively review/approve controlled documents to ensure quality attributes are met (i.e., non-conformances, procedures, technical studies, validation protocols, change controls, engineering documents, etc.)
- Assess and triage non-conformances that occur.
- Assist partners with writing change controls, deviations, and performing investigations
- Responsible for the oversight of specific Quality Management systems and/or Elanco Standards as assigned
- Provide a daily presence in the manufacturing environment to enable contemporaneous batch record review, provide quality guidance and expertise to production personnel, and provide trainings to production personnel and process team on quality topics.
- Prepares and submits annual operating and capital improvement budget requests to meet demand.
- 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 projects
- Performs other duties as required
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelors degree (science or engineering degree preferred)
- Must have a minimum of 5 years’ experience working in Quality field
- Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
- M.S highly desirable.
- A minimum of 5 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
- ASQ certification a plus.
- Experience working in an FDA or USDA regulated industry
- Demonstrate strong oral, written, and interpersonal skills
- Demonstrated ability to work on a team
- Demonstrated decision making and problem solving skills
- Root cause analysis and troubleshooting skills
- Proficiency with applicable computer systems
- Ability to lead without authority
- Demonstrated attention to detail and ability to maintain quality systems
- Technical writing skills
- Strong interpersonal and team building skills; ability to lead and influence in a team environment
- > 10% travel may be required
- 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