Lilly Site Quality Head in Overland Park, Kansas
Title Site Quality Head
City Overland Park
State / Province Kansas
Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Responsibilities Reporting to the Director-QA Elanco, the QA Manager 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 and to serve as a site agent to manage compliance to all cGMP procedures, standards, and common practices. This role also supports development of the site business and quality plans.
This position ensures that all operations supporting quality control testing requirements for manufacturing are performed in a regulatory compliant, safe, efficient, and environmentally responsible manner.
Position may have exposure to potential allergens or other environmental hazards. PPE required when working with allergens or other environmental hazards.
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, and Business Planning.
Driving the culture of “safety first - quality always”.
Owns Metrics for Quality.
Coaching, development and feedback to direct reports.
Participates in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports; and provides effective succession planning processes for key QA/QC positions.
Participate on the Site lead team and leads the Site Quality team.
Site and community engagement.
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.
Maintains technical and compliance consistency across the Site.
Coordinates and manages GMP related regulatory inspections.
Approves 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 Manager role for procedural requirements.
Have final decision authority at the Site on all Quality-related issues working together with the Site head.
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 Manager 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.
Drives relocation of the Quality Unit to the Lakeview Site.
Bachelor's degree or in a scientific field. Degree in Chemistry
10 years of experience in QA/ QC and/or QCL in a cGMP manufacturing environment.
5 years of experience in Quality supervisory and management skills, Production, Manufacturing, Science and Technology Services, Regulatory, or Administration
5 years of experience in organizing and leading FDA inspections
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.
Strong Quality knowledge
Exhibit clear understanding of all cGMPs, standards, procedures, and common practices
Written and oral communication skills
Critical decision-making skills
Knowledge of computer applications
Mentoring/leadership skills are required
Must be self-motivated
Language requirements – English
This position is located in Overland Park, Kansas.
Travel requirements are 10 percent or less.
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.
Removal Date 14-Oct-2017