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QIAGEN

Molecular testing consumables, instruments, software

Quality Control Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBeverly, MA, USAIn-person

About the Job

Requirements

  • A bachelor's degree in Biochemistry, Molecular Biology, Chemistry, Biotechnology, Bioengineering, or a related scientific discipline is required; a master's degree is preferred.
  • Eight to ten years of experience in molecular biology, enzyme or reagent manufacturing, in vitro diagnostics, medical device, biopharmaceutical, or other regulated laboratory environments.
  • Three to four years of demonstrated people leadership or laboratory management experience.
  • Proven experience leading Quality Control testing, technical investigations, and laboratory operations within a regulated environment.
  • Working knowledge of ISO 13485 quality systems and regulated laboratory practices.
  • Experience with deviations, corrective and preventive action, change control, validation, controlled documentation, and audit readiness activities.

Responsibilities

  • Lead and develop the Quality Control and Laboratory Operations team responsible for testing enzymes, nucleases, oligonucleotides, buffers, and formulated molecular biology reagents, ensuring safe, efficient, and inspection-ready laboratory operations.
  • Provide technical leadership and serve as the escalation point for enzyme and nuclease quality control, supporting assay performance, troubleshooting, investigations, and continuous improvement initiatives.
  • Ensure timely execution and review of quality control testing, batch release support, laboratory documentation, and data review in compliance with ISO 13485 requirements and data integrity standards.
  • Lead and support investigations related to deviations, nonconformances, out-of-specification and out-of-trend results, complaints, and corrective and preventive action activities; drive effective root cause analysis and long-term corrective actions.
  • Oversee method transfer, qualification, validation, and lifecycle management activities to support new product introductions, product transfers, and ongoing manufacturing operations.
  • Analyze performance metrics, identify trends, improve assay robustness, and implement process improvements to drive quality, compliance, and operational excellence.
  • Partner with Quality Assurance, Manufacturing, Technical Operations, Research and Development, Supply Chain, and external laboratories to support product release, regulatory readiness, and supply continuity.
  • Manage laboratory resources, priorities, and capacity to meet business objectives, while developing a high-performing team through coaching, training, and succession planning.

Desired Qualifications

  • A master's degree in Biochemistry, Molecular Biology, Chemistry, Biotechnology, Bioengineering, or a related scientific discipline.

About the Company

QIAGEN

Molecular testing consumables, instruments, software

QIAGEN provides molecular testing solutions for DNA, RNA, and proteins used by researchers and clinicians in life sciences and diagnostics. Its products support the full workflow from sample preparation to data interpretation through a portfolio of sample technologies, assay technologies, and bioinformatics software, including QIAseq UPXome RNA Library Kits, QIAstat Dx Viral Vesicular Panel, and the QIAstat Dx Analyzer. The company differentiates itself with an integrated end-to-end ecosystem that combines hardware, reagents, and software to streamline workflows and data analysis. Its goal is to help researchers and clinicians obtain fast, reliable molecular insights to support scientific discovery, diagnostics, and patient care.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Venlo, Netherlands
Founded
1984

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