Quality Control Manager

Posted 5 Days Ago
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Beverly, MA, USA
In-Office
105K-115K Annually
Expert/Leader
Biotech
The Role
Leads Quality Control and laboratory operations for molecular biology reagents in an ISO 13485-regulated environment. Oversees product testing, batch release support, investigations, CAPA, method transfer, validation, documentation, data integrity, and audit readiness. Serves as the technical escalation point for enzyme and nuclease QC while partnering with Quality Assurance, Manufacturing, R&D, Supply Chain, and external laboratories. Manages laboratory resources and develops a high-performing team through coaching, training, and succession planning.
Summary Generated by Built In

Overview  

 
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.  

We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams. 
 
We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you. 

 

At QIAGEN, every day is an opportunity to make a real-life impact. 

 

Join us, grow with us, and together, let's shape the future of biological discovery. 

‎

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  

 

  • Bonus/Commission  

  • Local benefits   

  • Referral Program  

  • Volunteer Day  

  • Internal Academy (QIALearn)   

  • Employee Assistance Program   

  • Hybrid work (conditional to your role) 

 

Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.   

 

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.  

Skills Required

  • Bachelor's degree in Biochemistry, Molecular Biology, Chemistry, Biotechnology, Bioengineering, or a related scientific discipline
  • Master's degree in a related scientific discipline
  • 8-10 years of experience in molecular biology, enzyme or reagent manufacturing, IVD, medical device, biopharmaceutical, or another regulated laboratory environment
  • 3-4 years of people leadership or laboratory management experience
  • Experience leading Quality Control testing, technical investigations, and laboratory operations in 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

QIAGEN Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about QIAGEN and has not been reviewed or approved by QIAGEN.

  • Flexible Benefits — Flexible work options (hybrid or remote where roles allow), flexible hours, sabbaticals, and site-specific childcare support work–life fit. Programs are presented as available where roles allow, signaling adaptable benefit design.
  • Wellbeing & Lifestyle Benefits — A global Employee Assistance Program for employees and immediate family, alongside broader wellbeing initiatives and community volunteering time, provides everyday support. Recognition for inclusive culture reinforces the emphasis on a supportive environment.
  • Parental & Family Support — Paid parental leave positioned as above typical U.S. norms and family-oriented offerings (e.g., on-site childcare at some locations) enhance caregiver support. Reports of solid PTO and holidays further strengthen family time.

QIAGEN Insights

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The Company
HQ: Hilden
6,000 Employees
Year Founded: 1984

What We Do

QIAGEN is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics).

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