Quality Manager, Investigations

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Division/Site: Our Whitby Site specializes in  commercial manufacturing  for a full range of  conventional dosage forms  with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility. Discover Impactful Work: Provide direction to the functions within   Investigations   in accordance with Regulatory and Corporate Quality Standards   &   Guidelines:    Deviation Investigations, Complaint Investigations, and Corrective and Preventive Actions to prevent recurrence.     Manage the daily activities of the   Investigations staff   to create a culture of quality awareness and teamwork , while coordinating investigations and working with the appropriate parties to complete product Deviation Reports (DRs)   and Complaint Reports .    Responsible for on time creation and issuance of Trend Reports to proactively identify   trending issues .  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 investigation s.   Evaluate thoroughness of investigation s   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 imp rovement 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   align ed   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.    S upport 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. Keys to Success:

Bachelor of Science (B.Sc.) in   C hemistry , Pharmacy   or a   science   related   to pharmaceutical