Quality Manager, Investigations

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:

• Accept Deviation Investigations and Complaint Investigations in order to initiate and lead the investigations.

• Evaluate thoroughness of investigations and determined root cause(s).

• Assign root cause and propose / assign Corrective Action Preventative Action (CAPA).

• Follows up on Investigations and CAPA actions to ensure on time closure.

• Monitor performance of Investigations and associated CAPAs through identification, monitoring, trending, and reporting of key performance indicators.

• Drive continuous improvement of Investigations, adoption of standard methodologies, application of consistency across the site, and ensure integrity of system in compliance with Regulatory, Corporate, and Site requirements.

• Ensure Investigations related procedures are aligned to Corporate Quality Standards and Guidelines.

• Attend client meetings as Investigations representative to provide guidance and strategic approach when required.

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

• Ensure timely issuance of Quarterly Investigations Trend Reports to proactively identify trends and initiation Trend Investigations unless there is an action plans in place to address them.

• Support Regulatory Inspections, Corporate Audits, and Client Audits specific to the functions within the Investigations team. Talk to auditors during inspections to ensure information is provided in a timely, accurate and complete manner.

• Perform as Site System Owner for Trackwise related 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.