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Eli Lilly And Company
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Lead/Senior Lead, GMQO

Lead/Senior Lead, GMQO

Eli Lilly And Company

6 - 13 years

20 - 25 Lacs

bengaluru

Posted:20 hours ago| Platform:

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Skills Required

escalations quality control iso process improvement auditing training pharmacovigilance root cause analysis coordination assurance quality analysis quality assurance compliance quality improvement leadership statistics communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned.

Recommends new quality system documents or changes to existing quality system documents where applicable.
Advise on appropriate training for implementation and documentation.
Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.
Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.
Complete self-inspections and drive improvements that are meaningful and actionable
Ensure local implementation of the quality systems as necessary.
Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.

Provide Quality Oversight for the Statistics business area

Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions.
Communicates and escalates to management as appropriate.
Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions.
Provide updates to quality and business owners.
Seek and implement simplification and process improvement.
Coordinate quality improvement initiatives.
Review metrics and trending to improve processes and compliance, as assigned.

Compile compliance metrics and maintain metrics process (for example, periodic report metrics).

Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports).

Monitor completion of deviations, change controls, CAPA, audit responses.

Audits and Inspections

Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).
Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)
Ensure completion of audit corrective action plans and timely resolution.
Leads and/or supports readiness activities in collaboration with business partners.

Partnership with the Statistics business area

Functions as the initial point of consultation for the Statistics business area on quality related questions.
Partners with the Statistics business area to strengthen and ensure appropriate quality controls are in place.
Shares key learning to drive simplification and replicate best practices
Collaborates with other quality groups as appropriate and develops quality network.
Establishes good working relationships with the Statistics business area.
Actively participates in team, business and quality related meetings.
Supports issue resolution including escalation.
Utilize a risk-based approach in guiding business areas.
Support key projects as assigned.
Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.
Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned.

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