Manager- Quality Audit, Metrics & Management Review

Main Purpose of the Role

• Core Job Responsibilities:

• Creates and maintains databases using Microsoft systems such as Excel, PowerBI and Forms to track/trend and monitor Quality data and documentation, to support the divisional metrics and management review program. Ensures the integrity, accuracy, consistency, and completeness of site and division data in the area of responsibility.
• Corresponds with operations sites and business units regarding inquiries and completion of documentation required by company policies and procedures.
• Division owner for Corporate Audit Database (ABTRAQ), including collating, documenting and reporting findings/actions plans, and tracking of all External Agency and AQR audit related data contained within the ABTRAQ system.
• Delivering training and support on QA IT Systems, such as ABTRAQ
• Liaise directly with AQR management for the purposes of reporting metric, audit and product action data
• Producing the highest quality results while operating within the constraints of the business timelines and guidelines. Responsibilities also include developing positive relations with other individuals within as well as outside the department.
• Uses discretion in escalating unusual product performance issues, collaborates with other functional areas to discuss and resolve.
• Participates in process improvement teams, strategic program development, risk assessments and other analytical teams responsible for the improvement of processes and regulatory activity.
• Interfaces with several multi-functional areas, such as Commercial, Distribution, Contract Operations, etc., to document, review, and resolve performance reporting issues.
• Provides support to management for event planning, meeting scheduling/planning/preparation, report preparation, correspondence/communications, and tracking department projects and timelines.
• In addition to the duties described, the incumbent completes all other projects as assigned by management as well as assures compliance to applicable Regulations and Good Manufacturing Practices

• • Minimum Experience/Training Required:

  • 5+ years of customer support, business, or project planning experience preferred.
  • Able to work independently and/or function with minimal supervision. Must be able to work under pressure and stress common to office environments.
  • Position requires a very high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to internal customers questions and requests.
  • Must be able to deal effectively with problems and internal customers.
  • Must be able to maintain a high degree of accuracy and analytical thinking.
  • Advanced knowledge of Microsoft Excel and PowerPoint are essential to the role
  • Experience in Metrics and Data Analytics systems such as PowerBI is desired
  • Excellent verbal and written English communication skills.
  • Must have knowledge of applicable regulatory standards and requirements for pharmaceutical products.
  • System experience using Trackwise, and general IT system data entry and report generation desired
  • Advanced level of English is mandatory, due to the nature of the role.

  • Minimum Education:

  • Required: Bachelor Degree in science, business, or technical related field to perform all aspects of the job.

  • Position Accountability/Scope:

  • The xxxxx reports directly to the Associate Director u2013 Quality Metrics and Management Review.

  • Supervisory/Management Responsibilities:

  • Direct Reports: N/A
  • Indirect Reports: N/A