Job Description
Eli Lilly Cork is a global healthcare leader headquartered in Indianapolis, Indiana, with a talented diverse team of over 1,800 employees across 38 nationalities.
We deliver innovative solutions that add value across various Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Purpose:
The purpose of the Associate/Senior Associate/Associate Consultant, IT Systems Business Quality Assurance (BQA) – Biometrics role is to support the development and implementation of quality systems strategy and activities to support the Data and Analytics and Global statistical science organizations goals and objectives for IT systems.
Primary Responsibilities:
* Ensure local implementation of the Safety and Efficacy Quality System (SEQS):
* Review regional and/or local SOPs versus global policies. Review quality system documents and provides feedback.
* Recommend new procedures or changes to existing procedures where applicable.
* Provide quality oversight for compliance to SEQS.
* Escalate compliance issues to management locally and globally as appropriate.
* Ensure inspection readiness and compliance to global, regional, and/or local regulations:
* Assist in interpreting relevant pharmacovigilance regulations and guidelines and acts as a contact person in the regional centre and/or affiliates.
* Perform quality self-assessments.
* Facilitate audits and inspections.
* Coordinate audit responses including Trackwise system documentation.
* Communicate and ensure inspection readiness requirements are in place; e.g. organization and availability of documents such as training records, job description, backroom and/or front room organization, etc.
* Ensure the implementation and maintenance of regional and/or affiliate Quality Plan(s):
* Document the regional and/or affiliate quality systems requirements ensuring clear accountabilities.
* Manage the regional and/or affiliate quality plan(s).
* Provide updates to quality and business owners.
* Implement and manage Quality Systems:
* Provide consultation on the integration of quality into business processes.
* Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
* Consult on root cause analysis for deviations.
* Drive trending of metrics to improve processes and compliance:
* Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.
* Monitor completion of deviations, CAPA related to deviations and change controls.
* Monitor completion of audit responses through metrics.
* Provide updates to management.
* Share key learning to drive simplification and replicate best practices in the region and globally.
* Coordinate quality improvement initiatives.
* Seek and implement simplification and process improvement.
* Information Technology Quality Support responsibilities:
* Review, and approve as appropriate, documents associated with the development and maintenance of IT systems.
* Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.
* Participate as a member of the IT Change Control Board as applicable.
* Coordinate interfaces with other related systems.
* Other responsibilities:
* Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections).
* Review and approve change requests and validation documentation for IT systems.
Minimum Qualification Requirements:
* Bachelors or Masters Degree in a science or health care related field.
* Minimum three years' experience in quality and/or data management or statistics.
* Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (GMP, GCP, etc.).
* Demonstrated ability to communicate effectively, both written and verbal, and to influence others.
* Demonstrated ability to prioritize and handle multiple concurrent tasks.
* Demonstrated ability to apply risk-based decision making in a regulated environment.
Other Information/Additional Preferences:
* Demonstrated ability to work in a global environment.