The Opportunity
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. Bio-Techne’s Molecular Diagnostics Division, which is comprised of the Asuragen and Exosome Diagnostics brands, develops molecular assays and software solutions that broaden access to care, answer unmet needs, and improve health outcomes through novel reagent systems and an industry-leading exosome enrichment technology for liquid biopsies.
Asuragen is a molecular diagnostic product company based in Austin, TX, changing the way patients are treated in genetics and oncology. Asuragen’s diagnostic systems, composed of proprietary chemistry and software, deliver powerful answers using broadly installed instrument platforms. They are simple to adopt and expand the ability to serve patients. Asuragen is a leading developer and manufacturer of cutting-edge molecular solutions (test kits, software, and controls) with a focus on oncology, inherited genetic disorders, infectious diseases and companion diagnostic products. With a global presence, we are committed to delivering high-quality solutions to researchers, healthcare professionals and laboratory diagnosticians worldwide. As we continue to build our innovative portfolio, we are seeking a highly skilled and experienced Senior Manager, Quality Assurance to join our dynamic team.
As the Senior Manager, Quality Assurance at Asuragen, you will play a pivotal role in maintaining and enhancing the quality management system for our IVD and RUO products. Your responsibilities will encompass overseeing quality assurance processes and driving continuous improvement initiatives to uphold the integrity and reliability of our product portfolio. This position requires a hands-on, strategic approach to quality assurance, including risk management, compliance, and continuous improvement initiatives.
What You’ll Do
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Quality Management System Leadership:
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Manage and maintain Asuragen’s comprehensive quality management systems aligned with global regulatory requirements and industry best practices.
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Manage, improve, and build upon Asuragen’s robust procedures and processes to ensure consistent adherence to quality standards throughout the product lifecycle.
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Upon designation, serve as Asuragen’s Quality Management Representative
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Compliance:
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Monitor changes to relevant Quality Standards; assess and communicate the impact of such changes to Management.
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Facilitate regulatory audits, notified body inspections, and customer supplier audits by working with cross-functional subject matter experts to provide objective evidence of Asuragen’s compliance with applicable laws, standards, and guidelines.
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Lead risk management activities, including the identification, assessment and mitigation of risks associated with product quality, safety, and regulatory compliance.
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Oversee and facilitate post-market surveillance activities including complaint management and customer notification processes.
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Quality Assurance Strategy:
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Define and execute strategic initiatives to enhance product quality, reliability, and customer satisfaction.
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Drive cross-functional collaboration to identify and mitigate quality risks across manufacturing, supply chain, and distribution channels.
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Quality Performance Monitoring:
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Monitor the effectiveness of quality assurance processes through established key performance indicators (KPIs) and metrics.
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Conduct thorough root cause analyses and implement corrective and preventive actions (CAPAs) to address non-conformances and deviations.
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Supplier and Vendor Management:
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Evaluate and qualify suppliers and vendors to ensure adherence to quality standards and specifications.
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Foster strong partnerships with external stakeholders to drive quality improvements and supplier development initiatives.
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Team Leadership and Development:
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Provide leadership, guidance, and development opportunities to the quality assurance team, fostering a culture of accountability, collaboration, and continuous learning.
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Conduct regular training programs to enhance team competencies and ensure alignment with quality objectives.
Who You Are & What You Bring
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B.S./B.A. degree in Biology, Chemistry, or related science.
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Minimum of 8 years’ experience in a Quality Assurance role in an IVD manufacturing environment with a proven record of developing a high-performing Quality Assurance team and robust Quality Management System.
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Demonstrated ability to identify and apply solutions to achieve company goals in effective and efficient manner.
- Knowledge and experience with novel molecular in vitro diagnostic assays, software, and devices (and accessories to IVD’s) is a plus.
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Strong results orientation and effective change agent.
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Demonstrated problem-solving skill set in the regulatory and clinical environment with good business judgment.
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Ability to flourish in a fast-paced, multi-tasking and dynamic environment with a high level of ambiguity.
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Strong written and oral communication skills. The ability to present effectively to a wide spectrum of audiences, both internally and externally.
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Ability to build strong relationships across a wide spectrum of internal and external parties.
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Creative and innovative thinker.
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Ability to work with cross-functional teams to guide and obtain required regulatory documents.
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Entrepreneurial mindset; small company experience a plus.
Who We Are and What We Offer
We have an incredibly talented group of down-to-earth professionals with the experience, drive, and creativity to make Bio-Techne a world-class life science solutions company. Our workplace is full of enthusiastic, hardworking, and intelligent people with bold ideas and the determination to see them through.
Our best-in-class diagnostic tests are used throughout a patient’s lifespan by laboratories worldwide. Asuragen is located in Austin, TX, which offers top-notch technology, educational, and business benefits.
Bio-Techne provides a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching, an employee bonus plan, and a tuition reimbursement plan. Additional components of compensation include stock option grants and an annual bonus plan. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Bio-Techne is an E-Verify Employer in the United States.