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Position Description:
As a member of a team dedicated to ensuring regulatory compliance for a network of vaccine manufacturing sites, the role will:
Partner with external consultants to compare existing Establishment 196 practices (Outlines of Production, Batch records, work-instructions, control strategies, etc.) to current compliance requirements
Develop a strategy (priority, timeline, owners, etc.) for improvements
Actively execute the strategy after approval by executive leadership
Periodically present progress to Executive Leadership
Though developing a strategy is a necessary component of this role, the focus is on the execution of the strategy—completing the improvements identified in the plan. This role will report to the manufacturing Site Head but will have significant exposure to executive leadership throughout the entire process.
Functions, Duties, Tasks:
Partner with functional leaders, Site Head, external consultants, subject matter experts, and executive leadership to develop a compliance roadmap for the vaccine manufacturing site(s)
Responsible for the execution and delivery of improvements through individual assignments and leading project teams
Create, present, and lead training on improvements to processes or procedures
Use technical skills to lead or participate in investigations, which may include change controls, deviations etc.
Prepare protocols as needed and author Technical Reports to support the compliance roadmap
Provide technical support through data analysis and trending
Communicate progress to off-site steering team
Replicate process for other vaccine manufacturing sites in the network
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.
Additional Preferences:
MS or PhD preferred
Experience providing technical support in a manufacturing environment
High level of technical troubleshooting ability in all engineering areas.
Experience working in a team oriented, collaborative environment.
Effective strategic, operational and management skills.
Excellent communication, leadership, problem solving and analytical skills.
Ability to rapidly adapt and respond to changes in environment and priorities.
Ability to elicit cooperation from senior management and other departments
Solid analytical and strategic capabilities and business acumen along with demonstrated work ethic, integrity, and professional conduct and appearance.
Experience in Lean, Six-Sigma or Operational Excellence
Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office
Other Information:
Travel may be required
PPE required in some working areas
Position may be located at any of our US manufacturing sites
Relocation assistance eligible
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
