Lilly Consultant-Global Quality Labs in Greenfield, Indiana
Monitor external regulatory and industry trends related to stability program management.
Network with manufacturing site quality to define a balanced and compliant stability plan that ensures selection of appropriate batches for annual stability monitoring program.
Optimize stability studies to provide scientifically justified stability data to support product shelf life, ensuring compliance with all appropriate guidelines and regulatory requirements.
Responsible for ensuring the regulatory and quality compliance for external stability testing, including all appropriate documentation.
Provide leadership and problem solving support to help drive the resolution and completion of all OOS/OOT stability investigations.
Summarize analytical data in accordance with cGMP and include the statistical evaluation of data trends.
Development and implementation of metrics and/or tools to monitor all aspects of study execution.
Ensure all changes to the stability program, commitments, and protocols are adequately documented.
Maintain internal documentation for external stability studies, and publish information through use of communication and information-sharing tools (e.g. sharepoint sites).
Perform any other duties or serve in such other capacity as may be determined by Company management.
Previous experience providing technical oversight of third party contract laboratory operations
Experience utilizing Regulus for document management
Experience utilizing Trackwise software for documentation of deviations and change controls.
Strong working knowledge of analytical laboratory operations with a focus on analytical chemistry and stability.
Previous experiences leading the execution of stability programs.
Strong working knowledge in GMP compliance with global regulatory requirements (FDA, MHRA, EMEA, etc.)
Ability to effectively communicate verbally and in writing
Ability to effectively influence remote teams and stakeholders
Strong problem solving skills and decision-making abilities
Ability to influence without authority and negotiate positive outcomes
Demonstrated ability in managing a variety of processes and projects
Ability to work independently and employ the initiative to find solutions, prioritize and exercise discretion
- Lilly 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.
Global Quality Labs
B.S. in chemistry or related analytical sciences
5 years of experience in a regulated environment within stability program management
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
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.
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