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Senior Manager, Quality Assurance Lab Operations

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

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 headquarters site with close collaboration with the CLIA QA LabOps team. The Senior Manager is responsible for oversight and management of the day-to-day operations of the Quality LabOps department in Cambridge 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 batch release, product release, technology transfer, 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.

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 and CLIA 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 the leading of the QA LabOps investigation team.

• Direct programs or procedures which assure the proper compliant manufacturing, the timely data analysis and reporting of trends and the completion of written investigations in response to unusual or unexpected results or deviations.

• Be a subject matter expert and strategist for audit-related questions within the subject matter area and beyond including front room and back room support and management for FDA, Notified Body, or pharma partners.

• 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.

• Assist with the expansion of the manufacturing program in compliance with IVDR, ISO 13485, and pertinent regulatory bodies.

• Lead Root Cause Analysis (RCA), Design of Experiments (DOE), 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 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 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 management team and mentor front line staff including directing training development for internal processes and department on-boarding of new staff.

• Act as a manager of quality professionals; ensure activities are completed in alignment with goals and ensure 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

• 4+ 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 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

 

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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