About the Job

The Senior Manager in the LabOps Quality Assurance department is an integral part of a highly productive team overseeing GxP activities at the FMI Laboratory site with close collaboration with the Laboratory Operations (LabOps) team. The Senior Manager is responsible for oversight and management of the day-to-day operations of the Quality LabOps department in Cambridge, MA with a global mindset ensuring continuity across all sites. This position leads various teams within FMI, directing quality personnel working with laboratory operations teams within the Quality System Program, including laboratory process review, batch release of products, laboratory assay verification and installation, material acceptance, non-conformance and CAPA investigation. The role works closely across all levels of a highly motivated and collaborative organization to ensure quality and timely execution of lab and quality requirements, adhering to compliance and safety standards while ensuring a patient-focused mindset.

This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.

Key Responsibilities

• Direct, advocate, and enable visibility of quality processes. Ensure accountability within all areas of the business unit (pre-analytical, analytical, and post-analytical).
• Serve as a member of project teams as necessary with participation in the applicable forums, providing GxP, CLIA, and laboratory accreditation compliance advice and regulatory guidance to achieve continuous quality improvement and effective quality monitoring (including risk identification/mitigation support for potential and identified operational issues or deviations).
• Manage, in collaboration with LabOps leaders, CAPA investigations, and conduct cross-functional investigations and mitigation plans for GXP systems.
• Establish and maintain collaborative relationships with key stakeholders.
• Provide guidance to FMI departments on CAPA and nonconformance investigations including leading the QA LabOps investigation team.
• In collaboration with the Licensure and Accreditation team, serve as the site head for all laboratory inspections and audits.
• In collaboration with Quality Systems and Clinical QA, serve as the site head for all FDA, Notified Body, or pharma partners audits and inspections.
• Direct programs or procedures which assure the proper compliant manufacturing when applicable, the timely data analysis and reporting of trends, and the completion of written investigations in response to unusual or unexpected results or deviations.
• Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, and international and national regulations, and are aligned with regulatory agency expectations.
• Act as a subject matter expert and strategist for audit-related questions within the subject matter area and beyond, including front-room and backroom support.
• Lead Root Cause Analysis (RCA), Corrective and Preventative Action (CAPA), LEAN, and similar continuous improvement initiatives with a solution-focused mindset.
• Assist in special projects, including off-site implementations, and activities as required.
• Suggest changes in working conditions and develop and establish measures to improve the efficiency and performance of the laboratory; strive to make the laboratory a model of efficiency, quality, safety, and service.
• Conduct root cause analysis and implementation of correction, corrective and preventative actions, and verification of the effectiveness of actions as periodically required in the identification and resolution of issues.
• Guide the organization on strategy and implementation of continuous improvement of the quality system.
• Supervise and develop the management team and mentor front-line staff including directing training development for internal processes and department onboarding of new staff.
• Act as a manager of quality professionals by ensuring activities are completed in alignment with goals and ensuring continuous development of personnel.
• Provide training and mentorship to less experienced members of QA staff across the QA organization.
• Ensure the work climate/culture within Quality System, exemplifies our Company's Leadership behaviors.
• Lead remote teams, as required.
• Perform batch review and release, as required.
• Perform material review and release, as required.
• Travel periodically (up to 10% of the time).
• Other duties as required.

Qualifications

Basic Qualifications

• Bachelor’s Degree in a science or engineering discipline
• 10+ years of experience in medical device, diagnostics, clinical laboratory, or biopharmaceutical industry
• 5+ years of management experience

• Preferred Qualifications

• Advanced Degree in the Sciences, Engineering, Business, or a related field
• ASCP or MT(AMT) Certification
• ASQ Certification
• Experience supporting a CLIA, QC and/or device laboratory
• Experience with next generation sequencing methodology
• Experience with IVD, or Medical Device product development, analytical validation and product approval
• Demonstrated ability to lead, communicate, interact, and influence effectively at technical levels across functions
• Demonstrated capacity to work in a fast-paced environment with strong attention to detail
• Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
• Evidence of knowledge of molecular biology
• Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international, standards set forth by the International Electrotechnical Commission and International Organization for Standardization
• Working knowledge of Next Generation Sequencing
• Comprehensive knowledge of Good Manufacturing Practices
• Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
• Proficiency in relevant analytical methodology and emerging new technologies
• Strong program and project management skills with experience in leading quality projects
• Strong skills in troubleshooting and problem solving
• Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
• Highly organized with strong attention to detail
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion

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