Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
The Quality Manager is responsible for the quality function at the Winslow site, ensuring programs and processes are in place to ensure compliance with Elanco Global Quality Standards, relevant regulatory authority expectations, and internal/external animal welfare regulations. The Quality Manager is responsible for leadership and supervision of the quality team including testing, release, and monitoring of operations and product distribution.
The Quality Manager will support and drive improvements across the entire lifecycle of products, including process design, change control, deviations, batch release, stability, complaint management, and performance data review. In addition, the Quality manager partners closely with other functions to ensure all decisions and actions are determined through the application of good science, risk management, and the most current regulatory expectations.
Functions, Duties, Tasks:
Ensures safety of QA and QC personnel through training, policies and systems development, and interface between QA/QC staff and the Safety Department.
Manage Quality Control Laboratories to provide a technically sound and timely QC testing function
Plans and sets objectives for QA and QC departments; evaluates quality department as a whole to ensure that all required knowledge and skills are available within the function.
Responsible for ensuring current Quality Plan is in place to drive continuous improvement.
Ensure Periodic Quality Reviews & Periodic Product Reviews are conducted
Provide oversight of investigations to resolve issues that may impact on the quality of manufactured product and ensure long term preventative solutions are implemented
Lead Product Recall activity on-site, as needed, ensuring compliance with both regulatory requirements and the requirements of the Elanco Quality Manual.
Ensure compliance of all activities performed by 3rd Parties or suppliers (i.e. Audit adherence; Quality Agreements), as required by applicable internal Standards and Regulatory authorities
Measure & monitor, in collaboration with other functions on-site, cGMP activities to ensure Manufacturing & Product licenses are maintained (the right to operate)
Develop talent to sustain local & network competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
Communicate period updates on the quality compliance status of the site.
Collaborate with Quality leaders within the Vaccines Network to embed the Vaccines network strategy at the site.
Participate in the site leadership team and ensure that quality platform is embedded across the site
Comply with all company local and global policies including Quality frameworks, Code of Conduct, 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 of Science degree in Science (Biology, Biochemistry, Chemistry, Engineering, Microbiology).
5 years’ experience in animal health or pharma manufacturing.
Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Masters or PhD degree in science field is preferred
Experience with inspection management FDA, USDA, EMEA, and others highly preferred
Knowledge of Continuous Improvement Six Sigma and Lean Principles
Demonstrated experience in the pharmaceutical or vaccine industry
Experience in Quality Operations, Manufacturing and/or other relevant operational areas, but must include Quality, managerial or project management experience.
Thorough knowledge of relevant vaccine manufacturing regulatory requirements.
Strong understanding of regulatory requirements for commercial global Vaccine processes
Demonstrated learning agility
Strong understanding of risk assessment and risk management fundamentals/tools
Technical understanding of Vaccine manufacturing/testing processes
Fluent in speaking / writing English
Location: Winslow/Waterville, Maine area
We offer a competitive relocation package for eligible candidates
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.