Supervisor, Complaints Investigations

Job Summary

Responsible for supervising Project Leader Complaint Investigators and the Coordinator Complaints processes at Richmond Hill manufacturing site in accordance with Regulatory requirements and Standard Operating Procedures (SOPs). Responsible to ensure that all complaint investigatoins are properly investigated in a timely and effective manner leading to root cause and corrective action determination.  Oversee generation of complaint investigation metrics, ensure complaint investigations sustainably achieve metric targets, trend reports are completed on time, and action plans are created for identified trends to mitigate risk. Responsible for supervising, developing, and coaching a team of complaint investigators.

Job Responsibilities

• Responsible to ensure all complaint investigations are investigated and documented in a manner which ensures compliance with site procedures and all applicable GMP’s.
• Develops and implements systems for improving complaint workflow and effectiveness.
• Works at intermediate and senior levels across the site and organization to ensure effective complaint investigation, root cause determination and appropriate corrective actions and preventive actions are identified.
• Responsible for complaint investigation data collection, analysis, and reporting for monitoring of complaint investigation performance and trend reports to be reported out at the Site Management Review.
• Responsible to manage escalation of complaint investigations and to mitigate risk by working with impacted departments to come to an agreement on a path forward.
• Analyzes complaint data and proactively identifies emerging trends and proposes measure to correct them.
• Leads, oversees, or participates in cross functional projects associated with complaint investigation reduction initiatives.
• Directly supervises a team working to investigate and close complaints.
• Coaches, mentors and trains staff to ensure that complaint investigations are of high quality, identify root cause and meet all GMP requirements.
• Facilitate daily huddles and weekly review boards to drive the performance of complaint investigations as required.
• Responsible to maintain site procedures for complaint investigation in alignment with corporate, global, and regulatory requirements.
• Responsible for supporting Regulatory Inspections, Corporate Audits, Client Audits, and Self-Inspections as the Complaint Investigation process and procedure owner.
• Provides performance management of direct reports providing ongoing feedback.
• Supervises the teams’ workload and ensures balance across the group, re-distributing activities as required.
• Works as a member of a team to achieve all outcomes.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

Job Requirements

• Education
  • BSc in Chemistry, Biology, Engineering or a related field.
    
    
• Knowledge, Skills and Abilities
  • Superior organizational, interpersonal communication skills including technical writing.
  • Ability to manage time effectively.
  • Ability to work independently and manage multiple priorities in a fast paced and changing environment.
  • Excellent command of the English language, both written and verbal.
  • Extensive knowledge of GMP requirements.
  • Proficiency with Word, Excel, SAP and Trackwise software.
    
    
• Experience
  • Minimum 7 years' experience in the Pharmaceutical Industry in Quality Assurance
  • Experience with quality oversight of Deviation and Complaint Investigations, Root Cause analysis tools, and Regulatory Audits