Full Time | United States
About the Job
Senior Manager, Document Control oversees document release, document change control, document approvals, the full electronic document management system, and records management for change and quality control, supplier quality, deviations, investigations, quality engineering, complaints, Corrective Action Preventative Actions and continuous improvement. Additionally, this position is responsible for review and approval of technical documents.
The position collaborates with remote site Quality Departments and provides recommendations for enhancement of Standard Operating Procedure (SOP) workflows, quality systems management, and quality assurance related systems.
• Provide oversight to the training program and system (Cornerstone)
• Ensure quality assurance annual training are managed in accordance with regulations and internal procedures
• Responsible for the management of regulated records
• Manage day-to-day document control activities in support of Lab Operations and R&D.
• Manage and maintain Electronic Document Management System (ie. MasterControl).
• Manage hard copy and electronic information storage and retrieval processes and systems.
• Provide system supports related to document control activities, such as Cornerstone.
• Manage Controlled External Standards processes and system.
• Administer and manage the document change system.
• Participate in defining and implementing improvements to current document control policies and processes.
• Lead backroom activities for external audits.
• Maintain all document control activities to FDA Quality Systems Regulation requirements, ISO 13485, ISO 15189, CAP/CLIA and state requirements.
• Provide Key Performance Indicators for management review.
• Supervise personnel and provide coaching, guidance, evaluation and hiring as needed.
• Other duties as assigned.
• Bachelor’s Degree
• 8+ years document control or engineering data related experience
• 8+ years of direct change control system management experience
• Advanced Degree (Master’s +)
• 3+ years in a supervisory control within quality control, quality assurance, or document management
• 3+ years of medical device industry experience
• Experience with:
· implementation and management of PDM / E Docs System
· change control, CAPA and deviation quality systems
· Management Information Systems implementation
• Strong knowledge of:
· SOP and Engineering specification creation and management
· cGXP regulations and guidance
· office application software
• Familiarity with GMP, 21 CFR Part 11, FDA GMP, MA & NYS regulations, CAP, CLIA
• Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving with departments and colleagues
• Track record of consistently meeting or exceeding project deadlines
• History of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
• Demonstrated ability to work well under pressure while maintaining a professional demeanor
• Understanding of HIPAA and importance of patient data privacy
• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration
Internal applicants, please use your FMI email address.
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