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Posted 3 months ago

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Manager/Senior Manager, Quality Assurance, Bioanalytical

LincolnHybridFull-time

AI Summary

Manages and oversees a Bioanalytical Quality Assurance team, driving QMS improvements, audits, and regulatory inspections within a global QA function.

About this role

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Are you a Bioanalytical Quality Professional with experience in quality assurance and team management looking to make an impact in a dynamic clinical research environment?
At Celerion, we're transforming clinical research through translational medicine. We're seeking a talented Manager/Senior Manager, Quality Assurance, Bioanalytical for our Global QA department to drive quality and compliance of our studies, processes and systems which is key to our mission of accelerating medicine for patients.
Ideally this role would be locally based at our Lincoln, Nebraska US location or alternatively at our Tempe, Arizona US location. Hybrid working and willingness to travel from other locations in the United States would also be considered.

What You’ll Do:

  • QA Bioanalytical Team Direction and Management
  • Driving QMS and Process Improvement Initiatives
  • Oversight of Study Audits, System/Process Audits and Vendor Audits
  • Hosting Sponsor Audits and Regulatory Inspections
  • Actively contributing to Global QA Strategy

    • What You’ll Bring:

  • Ability to communicate and interact at all levels within multicultural environment
  • Ability to organize and manage multiple priorities
  • Strong problem solving, comprehension and analytical skills
  • Collaborative team player, open minded, ethical and culturally sensitive
  • Ability to manage and resolve conflict
  • Good, well-developed leadership skills
  • Excellent written and oral communication skills
  • Attention to detail, tactful and diplomatic
  • Advanced Computer skills and literacy

    • What is Required:

  • Bachelor’s degree in Business, Science, or related field or equivalent experience
  • Minimum of 8 to 10 years experience in Quality Assurance
  • Minimum of 4 to 5 years team management experience
  • Proficient knowledge of GXP (specifically GLP and/or GCP) and FDA 21 CFR Part 11 regulations
  • Robust knowledge of Bioanalytical techniques, regulations and industry guidelines
  • Well-developed Pharmaceutical Industry network

    • Skills

    Audit ManagementBioanalytical TechniquesCAPACompliance TrackingDocument ControlFDA 21 CFR Part 11GCPGlobal QA StrategyGLPGxPInvestigationsProcess ImprovementQA ManagementQMS DeploymentQuality MetricsQuality SystemsRegulatory InspectionsRisk AssessmentSponsor AuditsSystem AuditsTraining & MentoringVendor Audits

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