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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.
Responsible for planning, conducting and reporting of quality audits according to national, international and Elanco requirements on veterinary Good Clinical Practice (vGCP), Good Laboratory Practice (GLP), and Good Research Practice (GRP) within Research and Development (R&D) including but not limited to, Regulatory Affairs (RA), Pharmacovigilance (PV), Marketing Affiliate and manufacturing of test articles/materials and/or investigational veterinary products for preclinical, clinical and post-marketing trials to ensure the quality systems, local/regional/global procedures and adequate resources are in place for effective implementation of the Lilly Quality Standards (LQS), Elanco Quality Standards (EQS), relevant national and international regulatory expectations including execution of the approved EGQCA Audit Plan.
Plan, coordinate, manage, support and/or lead audits according to the EGQCA audit plan in R&D, RA, PV and Marketing Affiliates activities in accordance with EGQCA audit programs, strategy and priorities.
Apply a risk-based audit approach for the identification of audit targets with the objective to optimize value, time and resources while minimizing business risks.
Perform quality assessments such as quality due diligence audit (QDDA) and/or pre-qualifications of Contract Research Organization (CRO), Contract Manufacturing Organization (CMO), Investigational sites, laboratories, third party contractors, suppliers and vendors for GCP, GLP, GRP, RA, PV and/or post-marketing activities.
Conduct routine systems audits of Elanco Marketing Affiliates and R&D sites, directed/for cause audits of focused specialized areas, mock audits or inspection readiness (as part of the regulatory inspection preparation for pre-submission/pre-approval/post-approval inspections) according to the requirements laid down in the relevant LQS/ EQS and the site specific Standard Operating Procedures (SOPs) .
Prepare and issue quality assessments and/or audit observations reports; assess adequacy of the auditee’s responses to audit observations/findings; approval and follow-up of Corrective Action and Preventive Action (CAPA) plan; and distribution of approved final audit reports.
Ensure appropriate notification to management (NTM) in case of critical observation/finding, significant quality deviations, and support immediate follow-up measures according to EQS.
Act as Subject Matter Expert (SME) in areas of expertise, as assigned by EGQCA management by providing sound guidance to Elanco associates, customers, stakeholders, business partners and management, where appropriate.
Support in preparation and/or during regulatory authority inspections and quality related corporate audit to ensure Elanco affiliates, R&D and investigational sites are prepared and supported.
Ensure proper management, follow-up and closure of audits to support the monthly reporting of key quality indicators (i.e., Leading and Lagging) associated with the audits, tracking and completion of CAPAs in the audit management database.
Communicate and liaise with internal and external stakeholders to drive quality mindset.
Bachelor degree in Science (e.g., agriculture, biology, chemistry, pharmacy) or related fields (e.g., veterinary)
5 years of clinical/industry/health authority experience in regulated industry, preferably (e.g., Clinical Trial Coordinator, Clinical Study Monitor etc.,)
+5 years Quality Assurance auditing experience
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.
Technical knowledge in PV, RA, and/or clinical drug development
Knowledge of product research and development
Knowledge of Regulatory Compliance and Industry Standards in veterinary GCP, GLP, PV and/or RA.
Excellent negotiation and interpersonal skills
Ability to communicate effectively (written and verbal)
This position will travel 50% of the time both domestic and international
Flexibility to work additional hours, as needed
Ability to undertake local, regional, interstate and international business travels.Fluency in English is essential.
Knowledge of other languages preferable.
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.