About the Job

The Quality Assurance Training Manager is responsible for overseeing quality deliverables in area of assignment and expertise maintaining a competitive advantage for FMI. This position supports the execution of the planning and work of multiple projects with a big picture mindset and is accountable for achieving all related business goals.

Key Responsibilities

• Oversee the overall GxP training program to provide a robust, compliant, streamlined training program that supports GXP operations and can withstand the rigor of regulatory inspections.
• Manage the day-to-day activities in the electronic training management system (Cornerstone).
• Maintain GxP training records and files.
• Partner with functional departments to create and maintain the training matrix for all.
• Instruct and administer Quality Systems classroom training when needed/onboarding.
• Participate in Inspection readiness activities to ensure the training program is continuously inspection ready.
• Support biopharma audit and inspection activities by being the training subject matter expert. Act as subject matter expert for audit-related questions within subject matter area and beyond, including front room and back room support and management for CAP, CLIA, FDA, Notified Body, or pharma partners.
• Participate in internal audits as needed.
• Provide training metrics to monitor the health and effectiveness of the training program.
• Participate in Quality Management Meetings representing training program performance.
• Develop effective cross-functional relationships with functional areas within FMI sustaining engineering and site management to meet departmental and organizational goals.
• Serve as engaging collaborator by building and maintaining strong relationships within FMI and serve as a liaison between functional departments and Quality.
• Track Quality Performance Metrics and participate in monthly quality reviews.
• Ensure regulatory requirements related business processes are implemented and maintain compliance.
• Support investigation activities for the determination of root causes of product and performance deviations (e.g. CAPAs and NCR).
• Act as a liaison with other functions to capture and analyze any requested changes against the product and regulatory requirements.
• Serve as technical reviewer for projects and programs across the FMI organization.
• Ability to travel up to 10% of the time.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s degree in science or engineering discipline with 5 years’ experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry OR 
• Master’s degree with 3 years’ experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry

Preferred Qualifications

• Demonstrated ability to work in a team environment effectively
• Demonstrated ability to effectively interface with internal and external teams
• Self-motivated, with a strong attention to detail and the ability to multitask
• Excellent written and oral communication with exceptional organizational skills
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion

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