Lilly Consultant-Auditor-Quality/Commercial in Greenfield, Indiana
The Quality Auditor is part of the Elanco Global Quality Compliance and Auditing (EGQCA) organization and provides quality assurance through the execution of internal and external audits in support of pharmaceutical products, product commercialization for Elanco. Through auditing, the Quality Auditor assures that operations conducted and sponsored by Elanco are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations and applicable guidelines and industry standards.
These responsibilities are not intended to be all-inclusive:
Scheduling, preparing, conducting and reporting Global Quality audits and assessments of commercial operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.
Participate in mock-inspections, as appropriate.
Participate in or lead the risk assessment of commercial operations. Integrate the information obtained through auditing and risk assessment and influence actions within and across EGQCA and the business areas involved/impacted.
Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.
Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
Participate in or lead the preparation of organizational metrics and trending of audit findings, when required.
Influence internal and external customers and partners when improvement needs are identified.
Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
Be continually aware of current industry trends and regulatory agency interpretation of requirements for Animal Health.
Participate or lead improvement efforts, including Six Sigma projects.
Ability to analyze detailed technical scientific information, while understanding the bigger picture. The auditor should be able to clearly identify and assess risk and impact associated with specific and overall findings and situation for an auditable unit, event or case, and to articulate such risk and impact when communicating to the business (including senior management) and the quality organizations.
Ability to interpret and apply regulations, regulatory guidance, codes and public expectations, and identify and recommend compliance changes as appropriate.
Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
Good analytical/problem-solving skills.
Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
Proven ability to think and analyze from a process perspective. Project management skills.
Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
Work independently as well as collaboratively within a global team environment.
Deliver constructive feedback to customers while providing a high level of customer service.
Ability to influence and manage change/conflict.
Establish and maintain effective working relationships at all levels internal and external to Lilly/Elanco.
Ability to think on your feet and be pragmatic in decision making
Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 50% (duration 1-2 weeks), sometimes on short notice.
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.
Bachelor’s Degree in Science (Chemistry/Science) + 3-5 years of auditing experience
Experience with computers, entering and managing data in databases.
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 animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com .
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