Lilly Consultant-Quality Systems in Fort Dodge, Iowa



This individual will be responsible for Quality System Leader oversight and will develop, improve and execute Quality procedures. The candidate will be responsible for maintaining compliance in the CAPA program, including leadership in the area of product complaints, manufacturing investigations, change control, document control, training, corporate metrics and KPIs. This role is a Quality Leader who provides team leadership according to company policies and corporate business plans. The expectations of the role will also be an individual who actively identifies risk areas and implements process improvements and risk mitigation plans and develops individual and team competencies at the site

Key Leadership Responsibilities

  • Leader of site CAPA and complaints systems

  • Leader of site execution of Change Control System

  • Provide oversight of the controlled document management system

  • Generate and report monthly metrics

  • Monitor Quality backlog items and partner with stakeholders to ensure on time closure

  • Identify process improvement initiatives for optimization and compliance

  • Coordinate inspection back room activities and ensure timely completion of all requests

  • Prioritize work, resolve issues, develop and institute quality and efficiency improvements

  • Provide technical guidance, training and oversight for Quality Systems personnel

  • Supervise and develop personnel

Key Technical Responsibilities

  • Excellent written and verbal communication skills, attention to detail and commitment to customer service

  • Proficiency in relevant computer software programs associated with the area

  • Draft, review and approve relevant SOPs, controlled forms and other documents

  • Assist with regulatory and corporate inspections and maintain inspection ready room

  • Support timely closure of deviations/investigations, CAPAs and change controls

  • Participate in internal audits and self-inspection (process, facility and documentation)

  • Ensures deviation events are thoroughly investigated utilizing root cause analysis techniques

  • Review and approve deviations, investigations and CAPAs

Req ID:


Additional Skills/Preferences:

  • Supervisory/Leadership experience at a highly regulated manufacturing organization

  • Expertise in the area of Quality Systems, including Change Control and CAPA

  • Business and technical competence, persistence/energy, planning and organizing, quality orientation and teamwork

  • Good understanding of the manufacturing requirements applicable to injectable/parenteral dosage forms

  • Proven project and people leadership skills

  • Formal Training and work experience in Quality Risk Management, lean manufacturing, and root cause analysis

  • Experienced in Interacting and communication with regulatory authorities in both written communication and inspection settings

Additional Preferences:

  • Masters Degree/Ph.D preferred

  • Lean 6 sigma black belt

  • Supervisory experience required in the area of biologics

Additional Information:

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


Workplace Arrangement:


Location Details:

Fort Dodge


Quality Systems- Leader

Job Category:


Basic Qualifications:

  • Bachelor’s Degree in Science or related scientific degree

  • 10 years recent experience in drug product, vaccine or biologics manufacturing

  • 2 years of experience administrating a CAPA Program

  • 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

Company Overview:

Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana


Fort Dodge



State / Province:



North America