We are seeking a highly motivated
Quality Control Manager to lead Quality Control activities supporting enzymes, nucleases, oligonucleotides, buffers, and formulated molecular biology reagents. In this key leadership role, you will provide technical and operational oversight for laboratory operations in an ISO 13485-regulated environment, ensuring timely product testing, compliant laboratory practices, and reliable support of manufacturing and product release activities.
You will serve as the technical escalation point for enzyme and nuclease quality control, lead laboratory investigations, support validation and transfer activities, and partner closely with cross-functional teams to ensure sustained compliance and uninterrupted product supply.
Your Tasks- 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 the timely execution and review of QC testing activities, 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, OOS/OOT results, complaints, and CAPA activities, driving 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.
- Drive quality, compliance, and operational excellence by analyzing performance metrics, identifying trends, improving assay robustness, and implementing process improvements.
- Partner closely with Quality Assurance, Manufacturing, Technical Operations, R&D, 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.
Your Profile- Bachelor's degree in Biochemistry, Molecular Biology, Chemistry, Biotechnology, Bioengineering, or a related scientific discipline; Master's degree preferred.
- 8-10 years of experience in molecular biology, enzyme or reagent manufacturing, IVD, medical device, biopharmaceutical, or other regulated laboratory environments.
- 3-4 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, CAPA, change control, validation, controlled documentation, and audit readiness activities.
The estimated base salary range for this position is $105,000 - $115,000. Compensation will be based on the candidate's experience, skills, geographic location, and other job-related factors. In addition to base salary, we offer a total compensation package that includes a bonus plan and generous benefits.
What we offer - Internal Academy (QIALearn)
- Employee Assistance Program
- Hybrid work (conditional to your role)
