R&D Quality Assurance Professional

Job Listing No: 9740000

R&D Quality Assurance Professional

?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:R&D Quality Assurance Professional provides quality oversight for animal health research and development activities at the site and in support of global projects, partnering with the business to meet the requirements of both Elanco and applicable regulatory authorities.This individual will develop strong partnerships and collaborations with Elanco R&D team members and act as a key contact for Quality related technical consultation.?This individual will proactively drive compliance through implementation and monitoring of Elanco Quality Systems, training and compliance tools.Functions, Duties, Task:Responsible for ensuring Quality oversight to all functions within the site R&D organization and for global projects.Responsible for establishing and maintaining the quality systems for the site. Will support the rollout of quality processes for the site, function or region.Coordinate preparation activities for regulatory authority inspections to enable inspection readiness at the site. Takes delegation for hosting inspections.Provide quality and compliance training to R&D personnel. Independently develops training presentations on GXP or compliance topics as needed, acts as a key contact for training topics.Has the depth and/or breadth of expertise and technical knowledge to be recognized as an expert in quality compliance for R&D area.Responsible for maintenance (initiation, review, renewal, etc.) of Quality Agreements with third parties for development activities.Builds relationships with business partners internal and external to R&D Quality and/or key R&D business area. Interacts with regulators, customers, and other outside stakeholders on business issues.Responsible for planning and conducting: GRP, GCP or GLP study protocol reviews, vGCP in-life and data/reports reviews/audits; ?site process self-inspections; and GRP, GMP, GLP or GCP qualification and oversight activities for work completed at third parties. Issues self-inspection reports, and reviews and approves responses and corrective actions. Considered an expert in at least one GXP standard area, and proficient in other GXP areas.Leads large scale projects or programs with moderate and higher risks.Independently completes release of investigational batches (drug substance/API, Drug product, vaccines), seed and cell lines, and other development materials as per Elanco R&D Quality System requirements.Responsible for the execution of the site quality assurance and compliance strategy for development through appropriate use of GCP (VICH GL9), OECD GLP, GMP, USDA and/or other relevant external standards and Elanco/Eli Lilly Quality System requirements.Provides expert quality compliance consultation to Regulatory affairsPerforms quality oversight of regulatory submission documentation for technical and clinical operations involving Site R&D operations.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 Site R&D.Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, anti-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 degree7 years experience in a regulated environment in product research and development??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 vaccine/animal health development experience, with a proven track record in R&D-related Quality Assurance.Experience with quality systems processes and training. ?Proven ability to operate in a business focused R&D Quality organization recognized as an expert and partner to both the R&D organization and CRO/CMO business partners.Expert knowledge in one of the following: GCP (VICH GL9), GMP or GLP compliance in one or more global regulatory requirements (USDA, CFIA, MHRA/VMD, EMA).Expert technical knowledge in one or more of the following fields for product development: technical development, biologics manufacturing, microbiology, clinical and/or safety.?Experience with quality compliance for regulatory submissions in support of veterinary health registrations. ?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.Strong analytical skills. Ability to set priorities and manage multiple tasks.Additional Information:Desired, advanced degree in Education listed above (e.g., ?Masters or PhD in Life Sciences)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: 23-Oct-2016

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