Global Quality Auditor

At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We\’re driven by our vision of \’Food and Companionship Enriching Life\‘ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you\’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals\‘ lives better makes life better – join our team today
Functions, Duties, Tasks:
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.
• Support training mentoring and qualification of new auditors to the team. 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.
• Lead in the assessment of Top 7 product supply chain audits to support uninterrupted product supply.
• Represent EGQCA in conducting Due Diligent audits to support the business in new acquisitions.

Minimum Qualification (education, experience and/or training, required certifications):

• 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.
• Experience with computers, entering and managing data in databases.
• Good analytical/problem-solving skills.
• Bachelor\’s Degree (or equivalent work experience) in physical or biological sciences, Engineering or other technical area.
• Minimum of 5 years previous auditing experience in aseptic manufacturing platforms.

Additional Preferences:

• Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
• Experiences in auditing of CSV and manufacturing of API would be appreciated.
• 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 Elanco.
• Ability to think on your feet and be pragmatic in decision making.

What we offer:

• Freedom for personal initiative and opportunities for individual further training
• Work in a dynamic team
• Subsidization of pension provision by the employer
• 40 hours / week
• 30 days vacation
• Health and fitness offerings
• in an international company
• Subsidized Job Ticket and bike leasing
• Encourage individual initiative and provide opportunities for personal development

Elanco 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