Sr. Associate Manager / Lead, GMQO

The purpose of the Associate / Senior Associate / Principal Associate u2013 MQO 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 Clinical Development.

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 Clinical Development business area

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

Partnership with the Clinical Development business area

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 :

Other Information / Additional Preferences :

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