Director-Qa

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Position Description:
Elanco is a Global Leader in pet and farm animal health products. With almost $5 Billion in revenue, our 9000 employees manufacture and market over 200 brands in 90 countries. The Elanco Clinton site manufactures multi-species products for the Global markets, encompassing products with FDA GMP, EFSA and EPA registrations. It is Elanco's largest natural product fermentation site in North America, and includes unit operations such as downstream processing, recovery and dry product formulation. The site is also a center of excellence for Companion Animal packaging of solid formulations.
The Quality Assurance Director is primarily responsible for the productivity and development of the employees, the quality of the product/results, and overall customer service. It is expected that the Quality Assurance Director oversees the department's daily workload planning, performance planning and issues, and regulatory compliance.Reporting to the Site Quality Leader, the Quality Assurance Director has responsibility for the QA group primarily supporting the Food Animal Manufacturing operations at the Clinton site. Regulations governing manufacturing in this area include 21-CFR-210, 21-CFR-211, 21-CFR-507, 21-CFR-226. The position has approximately 7 direct reports, within a Quality Assurance Organization of approximately 18 personnel.
Functions, Duties, Tasks:
Responsibilities of the Quality Assurance Director include:

• Ensures all aspects of Quality Management for applicable regulatory bodies are carried out according to the standards defined and is regularly reported and assessed for adequacy of performance.
• Manage/support the resolution of quality and technical problems in alignment with global standards
• Approval of deviations, procedures, protocols, and change controls
• Help ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product, are escalated as per standard procedures to management and are resolved within stated timelines.
• Support the Site Quality Leader in the development of the Quality Strategy and the Quality Planning.
• Help maintain readiness for HA inspections (PAI, directed, other)
• Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned
• Prepare and manage organizational Quality Assurance budget
• Exhibit cross-functional influence
• Work closely with Regulatory partners to support new product submissions, assist with responses to questions from Health Authorities and assure commitments to Authorities are met, e.g MCSR dates.
• Maintain and improve Quality Systems
• Ensure appropriate monitoring systems are in place for site systems (e.g., Utilities, Preventive Maintenance, etc.)
• Human Resource Development, Human Resource Planning and Performance Management for direct reports. Provide coaching/feedback.
• Assure appropriate quality governance through performance of management reviews of quality KPI's, metrics, process performance indicators and quality system signals. Initiate corrective actions when necessary and perform follow-up on resulting measures.
• Support deployment of operational excellence strategies to drive productivity.
• Work closely with Manufacturing and Supply Chain partners to assure business and quality objectives are achieved at sites and that a business partnership culture is maintained with Q and other cross-functional partners.
• Help develop a high-performance culture within the Quality Assurance organization
• Deploys Quality Risk Management Techniques for quality oversight and problem resolution.
• Mitigates unacceptable risk in conjunction with Elanco Manufacturing/Supply management and Quality.
• Ensures the Quality Assurance Agreements for Suppliers are created and maintained according to Elanco requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product.

Provide QA oversight of the following areas or systems and the people who support them:

• Manufacturing Operations - Clinton
• Stability Program
• Analytical Laboratories
• Self Inspection Program
• FAMIQS Certification

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

• Leadership, ability to influence diverse groups, administrative skills, project management skills, strong written and verbal communications skills, excellent teamwork and interpersonal skills, ability to organize and prioritize multiple tasks, exhibit independent decision - making skills, strong technical skills, knowledge of computer applications, and problem solving skills. Some US and OUS travel may be required.
• Strong understanding of regulatory requirements for commercial global DP/API processes. Proven track record with inspection management FDA, EMEA, and others. Strong understanding of risk assessment and risk management fundamentals/tools
• Bachelors or equivalent in a scientific field.

#LI_MNLN
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