Foundation Medicine · 3 days ago
Sr. Nonconformance Specialist
Boston, MA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $112K/yr
5+ years expFoundation Medicine is a biotechnology company focused on transforming cancer care through genomic profiling. The Nonconformance Specialist is responsible for overseeing the identification, documentation, investigation, and resolution of nonconformances within the QA LabOps Team, ensuring compliance with regulatory standards and driving continuous improvement.
BiotechnologyGeneticsHealth CareMedical
Responsibilities
Drives and oversees all nonconformance management activities to ensure compliance with applicable regulatory agencies and internal standards, including organizing, facilitating, and participating in investigations and resolution processes
Monitor trends and provide data to leadership
Inform department leadership of unfavorable trends before they result in noncompliance
Track phase turnaround time for all nonconformances
Lead and develop trainings on root cause analysis and nonconformance process
Coordinate root cause, investigation, and phase overdue meetings with stakeholders
Maintain complete and accurate records of nonconformance events, ongoing documentation for audits, and tracking corrective actions to resolution
Establish internal nonconformance management processes and ensure proper documentation and training
Manage the triage of new nonconformances and ensures proper assignment to the correct QA Approver
Promote internal and external customer satisfaction and a culture of service excellence by meeting the customer’s quality expectations
Provide detailed reports to the Sr. Director on feedback and suggestions on the Veeva NCR system
Conduct root cause analysis and implementation of correction, corrective and preventive actions, and verification of effectiveness as required
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
May assist in special projects, including site implementations and other activities as required
Other duties as assigned
Qualification
Required
Bachelor's Degree or equivalent experience
3+ years of experience in Nonconformance management within a regulated environment (biotech, pharma, or diagnostics)
5+ years of related professional experience
Preferred
Advanced degree in the sciences, engineering, business, or a related field
ASCP or MT(AMT) Certification
ASQ Certification
Experience supporting a CLIA, QC, and laboratory
Experience with next generation sequencing methodology; knowledge of molecular biology
Experience with IVD, or Medical Device product development, analytical validation and product approval
Demonstrated experience in overseeing initiatives and/or resources dedicated to laboratory safety and associated regulatory guidelines
Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international
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
Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow
Demonstrated ability to consistently meet or exceed project deadlines
Demonstrated ability to maintain confidentiality of business and proprietary information
Demonstrated knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
Strong collaboration skills with the ability to work with multiple stakeholders in a matrixed environment and to adjust accordingly to accommodate changing priorities
Strong skills in troubleshooting and problem solving
Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
Proficiency in relevant analytical methodology and emerging new technologies
Understanding of HIPAA and importance of patient data privacy
Commitment to reflect Foundation Medicine's values: integrity, courage, and passion
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for Foundation Medicine's benefits.
Company
Foundation Medicine
Foundation medicine is a molecular information company developing clinical diagnostic tests that facilitates personalized cancer therapies.
1001-5000 employees
H1B Sponsorship
Foundation Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (41)
2023 (30)
2022 (36)
2021 (41)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$96.5MKey Investors
Kleiner Perkins
2015-01-12Acquired
2013-09-25IPO
2013-01-08Series B· $13.5M
Leadership Team
Daniel Malarek
Chief Executive Officer
David Fabrizio
VP, Commercial Strategy and Medical Innovation
Recent News
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