Lead BQA - GMQO

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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. In support of this mission, the purpose of the role of BQA-Biometrics is to act as a quality consultant and leader in integrating the quality requirements into the business processes.  The BQA-Biometrics will implement the quality plan and ensure consistency between the global requirements and local requirements.  This includes the implementation of quality systems and assuring that these systems are aligned with appropriate quality and regulatory requirements.  The BQA-Biometrics will act as a contact person regarding quality and business process compliance concerns with IT Systems in the clinical data flow.

Primary Responsibilities:  This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.  Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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 center 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.
• 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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