About the Job

Associate Director, Quality Systems is responsible for the design, development, implementation and maintenance of a compliant and effective business level quality management system, Corrective and Preventative Action (CAPA) program, and management review program. This includes ensuring executive and senior leadership is informed of the effectiveness of the quality management system (QMS), and implementation of continuous improvement activities to maintain compliance and satisfy business needs. The role is additionally responsible for identifying and securing needed resources to ensure effectiveness.

Key Responsibilities

Partner with FMI senior management and Site Heads to harmonize the QMS across multiple sites. Collaborate cross functionally to identify and drive improvements and the integration of lean principles across the organization.  Serve as a subject matter expert on quality management systems and compliance across IVD medical devices, clinical laboratory and clinical trial disciplines.  Ensure sites are supported through implementation and effectiveness activities. Develop and manage Key Performance Indicators and own the execution of business-level Quality Management Review (QMR). Oversee core quality system functions including CAPA, NCR and QMR to ensure robust issue management and resolution. Lead the strategy and implementation of an electronic Quality Management System (eQMS), working collaboratively with IT, and cross functional teams. Function as the champion for information technology projects impacting the QMS function and/or systems. Design, establish, implement and maintain a resource plan that fully supports the needs of the business to maintain a compliant QMS. May manage and develop a team of quality professionals, providing coaching, evaluation and support for recruitment as needed. Travel domestically up to 30% for assigned work. Other duties as assigned

Qualifications

Basic Qualifications

Bachelor's degree in Science, Engineering or related field 10+ years of Quality Assurance experience in a biotech, pharma of medical device company 5+ years of experience managing or leading a team

Preferred Qualifications

10+ years in the biotechnology, pharmaceutical, diagnostic, or healthcare industries In-depth knowledge of ISO 13485, FDA CFR 820, IVDR, 21CFR Part11, and emerging standards and regulations Strong data analysis skills Superior interpersonal, verbal and written communication skills, with experience communicating concisely and clearly with a variety of stakeholders Excellent team building and leadership skills that motivate team members to drive projects to a successful conclusion, with experience managing and leading without direct authority Excellent situational analysis and judgement skill set, as it pertains to providing guidance and counsel to site and line staff Strong time management skills as an individual contributor and as a leader, with demonstrated ability to drive projects to scheduled completion Exceptional organizational, negotiation, and problem-solving skill sets Ability to travel up to 30% Understanding of HIPAA and the importance of patient data privacy Commitment to reflect FMI’s values: Passion, Patients, Innovation, and Collaboration

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