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Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Associate Director, Quality Systems

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job 

The Associate Director, Quality Management Systems is responsible for maintaining quality assurance operations, quality management formalized procedures, corporate quality systems, and quality functions. The incumbent provides continuous review of quality improvement technical documents and activities and is a designated approver in the quality assurance process. Partnering closely with remote site quality departments the position enhances systems, workflows, and tools used for quality systems management. Additionally, this position works with subject matter experts to investigate compliance related concerns.

Key Responsibilities

  • Lead the implementation of new QMS requirements and ensure continued compliance with existing QMS requirements found in the Food and Drug Administration Code of Federal Regulations Part 820, ISO International Organization for Standardization (ISO) 13485, 15189, 14971, CAP/CLIA, EU IVDR and other applicable regulations.
  • Plan and Lead the Quality System transfer to new facilities ensuring compliance to all internal and external requirements/regulations.
  • Establish, maintain track, and trend Quality System KPI’s (Key Process Indicators) and reporting to upper-level management
  • Independently develop and refine FMI Quality Management Systems processes compliance, alignment, and document hierarchy structure.
  • Ensure FMI’s QMS adherence to all domestic and international Standards/Regulations, Good Manufacturing Practice (GMP) regulations, current GMPs, and company policies.
  • Build strong partnerships with cross-functional peers developing strong collaborative partnerships.
  • Lead initiatives of FMI’s QMS certification and compliance programs across FMI.
  • Manage cross-site quality issues and implement a harmonized cross-site quality philosophy.
  • Participate in initiatives for standardizing quality operations across all FMI sites.
  • Translate and establish departmental goals aligning with FMI vision, purpose, and strategy.
  • Independently plan, develop, and lead projects to closure.
  • Manage, lead, develop, and mentor a Quality Systems team.
  • Make autonomous timely decisions considering impact to all aspects of the business based upon scope of responsibility.
  • Independently solve problems creatively.
  • Organize and delegate assignments to team members.
  • Travel up to 25% of the time.
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor's Degree in scientific or engineering discipline AND 8+ years of experience within a regulated pharmaceutical, biotech, diagnostics, or related health-care industry; OR
  • Master's Degree in science or engineering discipline AND 8+ years of experience within a regulated pharmaceutical, biotech, diagnostics, or related health-care industry
  • 8+ years of management experience in Quality Management System

Preferred Qualifications

  • 5+ years of managing CAPA procedures and documentation
  • Experience with Certified Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) certified laboratories within Quality Assurance
  • Extensive experience with a variety of quality management systems
  • Strong knowledge of cGXP regulations and guidelines
  • Experience in facilitating and utilizing tools for Root Cause Investigations
  • Operations experience in one of the following areas: Quality Assurance, Quality Control, Laboratory Operations Technical Support, Facilities Engineering, or Automation
  • Demonstrated experience with change control, CAPA and deviation quality systems
  • Experience with managing Quality Assurance activities across multiple quality system requirements (e.g., operating under both Food and Drug Administration Code of Federal Regulations Part 820, Clinical Laboratory Improvement Amendments, College of American Pathologists)
  • Experience with change management in constantly evolving environment(s)
  • Experience with state and federal privacy regulations and ability to develop and maintain expert knowledge of these requirements
  • Demonstrated ability to handle multiple priorities in a dynamic, fast-paced environment
  • Demonstrated ability to help scale functional area to include automated quality control
  • Demonstrated history of working with confidential information
  • Demonstrated history of independent problem solving
  • Strong interpersonal skills, demonstrated from professionalism in liaising with internal and external teams
  • Excellent attention to detail, time management, and investigative skills
  • Understanding of HIPAA and the importance of patient data privacy
  • Commitment to reflect FMI’s values: Passion, Patients, Innovation, and Collaboration

#Hybrid

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

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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Internal applicants, please use your FMI email address.

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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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