Associate Director, Quality Assurance

11 hours ago


Hazelwood, Missouri, United States BioFire Diagnostics Full time
Job Summary

We are seeking an experienced Associate Director, QA Technical Services to lead our quality technical services department. The successful candidate will be responsible for managing a team of quality engineers and validation engineers, ensuring the development and implementation of practical, innovative, sustainable, and efficient quality systems and approaches.

Key Responsibilities
  • Lead the quality technical services department, ensuring that each group has the technical and professional skills, organizational structure, capacity, and processes in place to maximize value.
  • Manage departmental staff to ensure due dates are met, coach and mentor, provide feedback, and work with employees to develop to their potential.
  • Provide quality oversight and technical proficiency to owning departments, including maintenance, calibration, production, industrialization, and engineering.
  • Support inspection readiness through audit preparation initiatives and coordinating continual regulatory compliance improvement.
  • Advance compliance improvement projects that promote confidence in the site from regulatory authorities and ensure patient safety.
  • Identify critical process parameters to align with risk assessment mitigations and critical quality attributes.
  • Create and integrate a robust change management program for changes and review the scientific rationale for changes made.
  • Responsible for ownership of the site validation master plan, leading the site validation program, and maintaining compliance to current validation standards and current industry practices.
Requirements
  • Requires a Bachelor's Degree in a technical or science-related field with a minimum of ten (10) years of experience in a regulated industry with five (5) years of experience in quality or validation work.
  • Five (5)+ years of experience managing large groups is highly preferred.
  • Must possess a thorough understanding of cGMPs, FDA validation requirements, ISO, and MDSAP standards and regulations.
  • Requires excellent written and oral communication skills to interact across all levels of the organization.
  • Requires expert skillset of risk analysis, problem-solving, statistical methods, and detail-oriented technical writing.
About Us

BioFire Diagnostics is a leading provider of molecular diagnostic solutions. We are committed to delivering high-quality products and services that meet the needs of our customers.



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