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The Site Quality Leader is responsible for both the Quality Assurance and Quality Control operations at the Winslow site, ensuring programs and processes are in place to establish and maintain compliance with Elanco Global Quality Standards, relevant regulatory authority expectations (focus 9CFR), and internal/external animal welfare regulations. This role is responsible for providing leadership and supervision to the quality team including testing, release, and monitoring of operations and product distribution. In addition, this role will support and drive improvements across the entire lifecycle of products, including process design, Change and Deviation management, batch release, product stability, complaint management, and performance data review.
While reporting to the Executive Director of Quality located in Indianapolis, IN, the Site Quality Leader Quality partners closely with the Winslow Site Head and other functional leaders to ensure all decisions and actions are determined through the application of good science, risk management, and the most current regulatory expectations. As part of the Site Leadership Team, the Site Quality Leader acts as a business owner to ensure that overall site goals are met and aligned with the Elanco corporate goals.
Functions, Duties, Tasks:
- Ensures safety of QA and QC personnel through training, policies, and systems development. Interface between QA/QC staff and the Safety Department.
- Operate as a member of the Site Lead Team on local initiatives and business plans, both within Quality and across the operation. This includes leading the site Quality Lead Team.
- Partner with Elanco Regulatory resources to establish and maintain compliance to 9CFR Vaccine manufacturing requirements as well as Elanco Global Quality requirements to ensure Manufacturing & Product licenses are maintained (the right to operate)
- Develop and ensure standardization of processes and approaches with the broader Network of USDA registered manufacturing facilities.
- Ensure the Quality Assurance team provides front line operational support as active members of process teams.
- Develop the organization to improve technical depth and capabilities related to US Vaccine manufacturing. This includes identifying individuals with technical and/or leadership potential for succession planning, or recruiting talent as needed.
- Manage Quality Control Laboratories to provide a technically sound and timely QC testing function
- Through the partnership of the Site Lead Team, drive continuous improvement through development and execution of a robust Quality Plan
- Ensure robust root cause investigations are conducted with appropriate CAPAs to resolve issues that may impact the quality and/or regulatory compliance of manufactured product
- 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
- Communicate period updates on the quality compliance status of the site.
- Collaborate with Quality leaders within the Vaccines Network and the broader Elanco Quality organization.
- 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. Minimum Qualification (education, experience and/or training, required certifications)
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelor of Science degree in Science (Biology, Biochemistry, Chemistry, Engineering, Microbiology).
- A minimum of 10 years’ experience in animal health or pharma manufacturing.
- Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
- 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
- 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
- Proven track record with inspection management FDA, USDA, EMEA, and others
- Strong understanding of risk assessment and risk management fundamentals/tools
- Technical understanding of Vaccine manufacturing/testing processes
- Fluent in speaking / writing English Other Information:
- Strong interpersonal skills and the ability to influence cross functionally