Associate Consultant Medical Quality

Company Name:
Eli Lilly
Company Overview:
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
The North America Site and Affiliate Quality Team currently have an immediate opening for an Associate Consultant. Associate Consultants on this team play a key role in leading clinical trial site pre-inspection preparation activities and providing on-site support during regulatory inspections. In addition, Associate Consultants provide input and guidance to the business to enable execution of internal and external regulations on a cross functional level, ensuring compliance and inspection readiness. The following are the key responsibilities of the Associate Consultants on the North America Site and Affiliate Quality Team:
Has awareness of inspection trends in North America
Is actively involved in leading pre-inspection preparation activities in collaboration with business partners
Prepares and educates internal and external business customers/partners (including investigator site staff) on inspection management
Hosts and/or participates in inspections
Responsible for inspection response management and tracking through resolution
Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections
Functions as an expert in corrective and preventative actions (CAPA) management
Supports and educates the business in developing robust CAPA, deviation management, root cause investigation, audit response management and inspection response management
Reports issues thorough Notification to Management (NTM) as appropriate
Performs on-going risk assessments in area of responsibility to identify performance/compliance gaps relative to current regulations, company standards and procedures and guidelines
Supports Medical Quality Systems (MQS) implementation and education of the business
Serves as the initial point of contact for the business on MQS related questions
Responsible for providing input and feedback on quality standards and expectations
Uses a risk based approach for effective communication to influence business decisions
Basic Qualifications:
Bachelors Degree in a science, technology or medically-related field.
2+ years of experience in quality and/or related field.
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.
Additional Skills/Preferences:
Extensive knowledge of GxP (GCP, GLP, GMP) regulations, guidelines and standards
Demonstrated understanding of quality management system principles, including policies, procedures and processes
Demonstrated ability to identify and prioritize quality issues
Knowledge of the relevant regulatory framework
Ability to work effectively at all levels of the organization
Effective organization/self-management skills
Excellent problem solving skills and initiative
Proficient written and spoken English language skills
Effective verbal communication
Additional Information:
This is a regionally based position in the United States.
Must have the ability to travel extensively to support inspection preparation and on-site support during regulatory inspections.
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
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