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.
Reporting to the Executive Director Quality, the QA Director has overall accountability for and provides oversight to all aspects of operation of the Quality Assurance and Quality Control Lab departments at Elanco Kansas City. To serve as a site agent to manage compliance to all cGMP procedures, standards, and common practices. To support development of the site business and quality plans.
This position ensures that all operations support quality control testing requirements for manufacturing are performed in a regulatory compliant, safe, efficient, and environmentally responsible manner.
The responsibilities of the Quality Assurance and Quality Control Manager include:
• Leadership to direct reports including employee development.
• Benchmarking with other sites to learn and apply best practices
• Strong partnership and communication with Operations, QA/QC, Regulatory, Supply Chain, Finance, and other areas.
• Proper documentation and use of HR processes.
• Participation in Lead Team, Site reviews, Business Planning
• Driving the culture of safety first - quality always
• Change Management
• Coaching, development and feedback to direct reports.
• Site and community engagement
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports; provides effective succession planning processes for key QA/QC positions
• Serve as a conduit for Corporate and Plant communications, objectives, projects and best practices. Strive for integration of best practices and elimination of waste across the site.
• Maintain strong ties across the QA and QCL with the goal of implementing consistent business/quality processes
• Creates, manages, and insures implementation of the Site Quality Plan
• Maintain technical and compliance consistency across site
• Coordinate and manage GMP related regulatory inspections
• Approve site GMP standard operating procedures defining Quality Systems
• Approve vendors and third parties
• Review/approve validation documents and site GMP standard operating procedures defining Laboratory Systems
• Fulfills Site Quality Assurance Director role for procedural requirements
• Have final decision authority at the site on all Quality related issues working together with site head, in alignment with his/her supervisor.
• Ensures that all operations necessary to support the quality control testing requirements are performed in regulatory compliance, safe, efficient and environmentally responsible manner
• Fulfills Site Quality Assurance and Quality Control Laboratory Director role for procedural requirements, including approval of appropriate change controls, deviations, and OOS investigations
• Provides suitably qualified resources of appropriate education, experience and training to staff Quality Assurance and the Quality Control Laboratory
Basic Minimum Requirements:
- BS or equivalent in a scientific field. Degree in chemistry with pharmaceutical laboratory experience.
- Experience in QA and/or QCL in a cGMP manufacturing environment is mandatory.
- Knowledge of analytical development and validation
- Problem solving skills.
- Demonstrated supervisory and management skills,
- Knowledge of regulatory and safety requirements including FDA.
- Strong quality knowledge, exhibit clear understanding of all cGMPs, standards, procedures, and common practices.
- Prioritization skills, written and oral communication skills, critical decision-making skills, interpersonal/people skills, knowledge of computer applications, problem solving skills, and mentoring/leadership skills are required.
- Must be self-motivated.
- Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Some US travel may be required.
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
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