Quality Leader Regulatory Affairs

Job Listing No: 9740000

Quality Leader Regulatory Affairs

??Company Overview: ? ??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.??Responsibilities : ? ?Responsible for the functional Regulatory QA program, providing leadership in business partnering & compliance to meet Elanco requirements.Lead functional Quality team that executes strategy for quality assurance operations and compliance in Regulatory.Proactively drives compliance through implementation and monitoring of ELANCO Quality Systems, training and compliance tools.Implement strategic QA planning and activities for Regulatory to meet global, internal and external, customer needs.?Functions, Duties, Task:Responsible for the execution of the global quality assurance and compliance strategy for Regulatory operations through appropriate use of GxP & other relevant external standards & regulations and Elanco / Eli Lilly Quality Standards.Responsible for ensuring Quality oversight to all functions within the Regulatory organization.Provides Quality leadership for Regulatory operational units. Assures adequately trained and knowledgeable QA resources necessary to support Regulatory operations are available.Manages product and site compliance issues, and provide assistance to sites, country business units, and organizations to assure overall success in Quality and regulatory compliance.Provides quality leadership to global functions and CBUs with respect to regulatory compliance for Regulatory ? managing reporting to internal and external stakeholders; developing and implementing robust training platforms; supporting policy development and supporting the consistent application of the interpretation of regulations and guidance documents.Establishes communication and reporting mechanism to assure adequate decisions and management attention is appropriately directed. Assures there is appropriate governance and management escalation processes for Quality within Regulatory.Provide expert opinion and ensure legal, regulatory and quality compliance.Develops in depth understanding of operational and business requirements, workloadpeaks, and planning processes to assure the appropriate alignment of Quality and Regulatory.Maintains assignment plans for Regulatory QA workload. Communicates and coordinates with other Quality groups, including Global Audit and Compliance, to assure activities are completed.Coordinate cross functional quality activities with respect to regulatory activities.Provide Quality support to Regulatory affairs at a global level, including development of systems to assure life-cycle file compliance.Develops and maintains systems to assure quality oversight of regulatory submission documentation, for technical and clinical operations.Oversight of systems to ensure that proposals and changes to regulatory requirements are appropriately communicated.Develop Regulatory QA talent to sustain local & global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.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.?Basic Qualifications ?? ?Bachelor?s Degree in Pharmacy, Science, Engineering, or related scientific degree .5 years experience in a regulated Quality Assurance role.2 years managing global projects.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.?Additional Skills/Preferences ?? ?Demonstrated pharmaceutical drug/animal health development experience, with a proven track record in R&D-related Quality Assurance leadership.Demonstrated matrix management experience.Expert knowledge in their functional area in one or more global regulatory requirements (FDA, MHRA, EMEA).Expert technical knowledge in their functional area.Direct experience with regulatory agencies.Knowledge of PC tools including all MS Office applications and InternetKnowledge of business process and the ability to work within the general business hierarchy.Ability to negotiate favorable outcomes while maintaining positive working relationship.Skilled in risk-assessment methodologies, and project organization.Able to interpret regulations and policies, and to communicate and respond to associated questions.Ability to define problems, collect and review data, establish facts and draw valid conclusions.Ability to effectively communicate verbally and in writing.Strong leadership skills. Ability to effectively work with teams and in a matrix environment.Strong analytical skills. Ability to set priorities and manage multiple tasks.Desired, Masters or PhD in Life Sciences or Management??? ?Additional Information ?? ?Expected Travel : Up to 15-20%Oversight of Affiliate Regulatory Quality Operations, providing training and support as required.Sitting on the RDQA Leadership team and other governance bodies as required.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.?Removal Date ?? ?20-Dec-2016?

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