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
LI-Hybrid
30+ days ago