Lead/Senior Lead, GMQO

The purpose of the Senior Associate/Lead/Senior Lead, GMQO is to support the development and implementation of the strategy for quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and Data Management.

Primary Responsibilities:

Implement and Manage Quality Systems

• 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.u00A0 Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned.u00A0

• 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.u00A0
• 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.u00A0
• Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.

Provide Quality Oversight for the Data Management business area

• Monitor for compliance to quality system documents.u00A0 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,u00A0 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 Data Management business area

• Functions as the initial point of consultation for the Data Management business area on quality related questions.
• Partners with the Data Management 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 Data Management 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.u00A0

Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.u00A0

Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality.u00A0

Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems.u00A0

Minimum Qualification Requirements:

• Bacheloru2019s Degree in a science/technology/health care related field or equivalent work experience
• Demonstrated ability to apply quality systems within a regulated work environment
• Effective project and time management skills
• Demonstrated ability to communicate effectively, both written and verbal, and to influence others
• Demonstrated ability to prioritize and handle multiple concurrent tasks
• Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
• Strong interpersonal skills with demonstrated flexibility in varying environments/geographies
• Effective organization/self-management skills

Other Information/Additional Preferences:

• Experience in a quality control/quality assurance role
• Experience in the Data Management business areas.
• Knowledge of quality systems
• Ability to work independently and as part of a team

Demonstrated ability to work in a global environment

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Lillyu00A0does 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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