Day in the Life:

• Manage the team responsible for Site and Product Investigations: Deviations and Complaints

• Direct and prioritize the Investigations team to ensure regulatory requirements, client commitments, and production needs are met.

• Coach on the Investigation process writing quality investigations.

• Assist in training and development of Investigators, providing performance feedback.

• Removes barriers

• Mentor the team to create a culture of quality awareness, teamwork, compliance, and continuous improvement with a focus on strong cross functional service throughout the site.

• Investigation Report Process

• AcceptDeviation Investigations and Complaint Investigationsin order to initiate and lead the investigations.

• Evaluate thoroughness of investigationsand determined root cause(s)

• Assign root cause and proposeassign Corrective Action Preventative Action (CAPA).

• Follows up onInvestigations andCAPA actionsto ensure on time closure.

• Monitor performance of Investigationsand associated CAPAsthrough identification, monitoring, trending, and reporting of key performance indicators.

• Drive continuous improvement ofInvestigations, adoption ofstandard methodologies, application of consistency across the site, and ensure integrity of system in compliance with Regulatory, Corporate, and Siterequirements.

• EnsureInvestigationsrelated procedures arealignedto Corporate Quality Standards and Guidelines.

• Attend client meetings asInvestigationsrepresentativeto provide guidance and strategic approachwhen required.

• Host and facilitate daily huddles and weekly review boards in support of driving the performance ofInvestigations

• Ensure timely issuance of QuarterlyInvestigationsTrend Reports to proactively identify trends andinitiation Trend Investigations unless there is anaction plans in place to address them.

• SupportRegulatory Inspections, Corporate Audits, and Client Auditsspecific to the functions within theInvestigationsteamTalk toauditors during inspections to ensure information is provided in a timely, accurate and complete manner.

• Perform as Site System Owner for Trackwiserelated to Investigations(i.e. support troubleshooting, provide support to end users

• Communicate issues that potentially affect product quality/compliance to the attention of Leadership.

• Support special projects as assigned.

• Promote a safe working environment, report potential hazards and ensure all direct reports follow Environmental Health and Safety procedures.

• Select, develop and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures.