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Quality Assurance Manager

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Position Summary

The Quality Assurance Manager oversees all activities to ensure that Flagship’s tissue analysis programs meet the high quality standards of our internal teams as well as those of our clients and regulatory agencies. Flagship Biosciences develops and implements novel technologies that require the development of new approaches for satisfying established standards in research and clinical trials applications. Flagship’s operations must comply with strict internal and regulatory (for example CLIA) guidelines and are typically audited by our clients approximately once a month as well as regulatory agencies (FDA, CLIA, etc.) at potentially unknown times. This position requires a resourceful manager with outstanding writing and organizational skills with strong experience in quality assurance. This person will work across multifunctional teams to develop, implement and maintain quality system programs. This includes conducting training and managing internal, external, client, and study audits on a regular basis.

Job Classification:  Full time, exempt

Reports to:  Chief Operating Officer with dotted line responsibility to the Chief Executive Officer and Medical Director

In This Role You Will:

  • Develop, maintain, and manage multiple quality systems simultaneously (research, clinical, CLIA, 21CFR820, ISO 13485)
  • Manage day-to-day activities of Quality Assurance Department
  • Management of Corrective and Preventive Actions (CAPAs) and Complaint Handling
  • Monitor performance of Change Requests and Document Controls
  • Facilitate audits and perform follow-up activities with Flagship clients and regulatory agencies including audit responses.
  • Manage and conduct Internal Audits
  • Develop new documentation for regulatory growth in new areas (e.g. new laboratory services, FDA, GCP, CAP/CLIA, etc.)
  • Represent Flagship’s regulatory needs both internally and externally
  • Assist with Supplier qualification, documentation, and guidelines with vendors and outside services
  • Influence compliance for Training Program Requirements for new hires and recurrent training
  • Train personnel on working in a regulated environment in quality assurance and regulatory activities
  • Prepare quarterly indicators report and present to upper management
  • Other duties, projects as assigned

About You:

  • Bachelor’s Degree in a science related discipline and
  • 5+ years’ experience in a regulated scientific, medical device or healthcare area with direct QA/QC experience
  • Demonstrated track record working with quality systems
  • Superior organization skills with a focus on attention to detail and accuracy
  • Ability to interact with auditors and customers in all regulatory affairs situations
  • Superior writing skills with experience writing SOPs and reports
  • Proficient in MS Office (Word, Excel and PowerPoint at an intermediate level)
  • Demonstrated ability to manage/prioritize multiple tasks simultaneously
  • Ability and desire to work in a fast-paced, changing environment
  • Excellent interpersonal and communication skills
  • Ability to interact/communicate effectively across all departments and levels of the organization
  • Quick learner with excellent judgment and problem solving skills
  • Upbeat attitude and willingness to adapt to changing situations

Preferred Qualifications

  • Master’s Degree in a science related discipline and 5+ years’ experience in a regulated scientific, medical device or healthcare area with direct QA/QC experience
  • Advanced regulatory coursework or degree in regulatory science or regulatory affairs
  • Regulatory Affairs Certificate (RAC) from Regulatory Affairs Professional Society
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