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Sr Dir, Quality Systems

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

Senior Director, Quality Systems is responsible for the design, development, implementation and maintenance of a compliant and effective business level quality management system, internal audit program, Corrective and Preventative Action (CAPA) program, document control program, training program and management review program. This includes ensuring 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 management to facilitate the QMS across multiple sites.

• Partner with cross functional team members to drive quality improvement activities and lean principles within the organization.

• Serve as the expert on quality management systems and compliance across IVD medical devices, clinical laboratory and clinical trial disciplines, and ensure sites are supported through implementation and effectiveness activities.

• Develop, establish Key Performance Indicators for, and act as an owner of business Quality Management Review (QMR).

• Lead and oversee the change management, CAPA, QMR, internal audit, and training functions for the organization.

• Function as the subject matter expert on change control, internal audits, and CAPA during external audits and inspections by regulatory authorities.

• Formulate a strategy on electronic QMS implementation and on driving implementation activities collaboratively with cross functional partners.

• Drive continuous improvement and LEAN activities with the sites to improve efficiencies in execution of the QMS.

• Function as the champion for information technology projects impacting the QMS function and/or systems.

• Ensure each site has an effective training program and maintains compliance with regulations.

• Design, establish, implement and maintain a resource plan that fully supports the needs of the business to maintain a compliant QMS.

• May manage a team of direct reports and provide guidance, coaching, evaluation and hiring of quality assurance personnel as needed.

• Travel domestically up to 30% for assigned work.

• Other duties as assigned

Qualifications

Basic Qualifications

• One of the following education or experience combinations:

·   Bachelor’s Degree and 8+ years of IVD medical device or laboratory quality assurance experience; OR,

·   Master’s Degree and 6+ years of IVD medical device or laboratory quality assurance experience

• 5+ years of experience managing direct reports

Preferred Qualifications

• 12+ years of Quality Assurance experience

• 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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