Associate - IT Systems Business Quality Assurance (BQA), Medicines Quality Organization (MQO),

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The Associate Consultant, IT Systems Business Quality Assurance (BQA) – Biometrics is responsible for quality oversight of IT systems in the clinical data flow within the scope of the Data Management and Global Statistical Sciences functions.  This role will support or AI/ML and automation initiatives and leverage Lilly’s expectation of high quality clinical data to enable innovation with a strong focus on data integrity. 

Role Purpose:

The purpose of the Associate Consultant, IT Systems Business Quality Assurance (BQA) – Biometrics role is to support the development and implementation of quality systems strategy and activities for IT systems in the Data and Analytics and Global statistical science organizations. The role acts as a quality consultant and leader to integrate quality requirements into business processes, ensuring consistency between global and local requirements. It involves implementing quality systems aligned with appropriate quality and regulatory requirements and serving as a contact person for quality and business process compliance concerns with IT Systems in the clinical data flow.

Responsibilities:

Ensure implementation of the Lilly's Global Quality Standards

• Review 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 global quality standards

• Escalate compliance issues to management locally and globally as appropriate

Ensure inspection readiness and compliance to global, regional, and/or local regulations

• Perform quality self-assessments.

• Facilitate audits and inspections.

• Coordinate audit responses

• 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.

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 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.
   

Requirements:

• Bachelors degree in a science, health care, data or computer systems related field.

• Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (GMP, GCP, etc.).

• Demonstrated ability to apply risk-based decision making in a regulated environment.

Additional Preferences:

• Three years’ experience in quality and/or data management or statistics.

• Demonstrated ability to communicate effectively, both written and verbal, and to influence others.

• Demonstrated ability to prioritize and handle multiple concurrent tasks.

• Qualifications or training in computer systems, data science, artificial intelligence/machine learning

• Demonstrated ability to work in a global environment.

Additional Information:

• This position is based in Indianapolis and the expectation is 3 days in office per week.

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