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This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is fully remote but requires EST hours to be worked.
General Summary
The Sr. Manager, Biomarker Operational Quality provides leadership and oversight of quality activities supporting biomarker and companion diagnostic (CDx) development from research through commercialization. This role partners with internal stakeholders and external developers to ensure quality, compliance, and operational excellence across clinical validation, regulatory transition, and commercialization activities.
Key Responsibilities
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Identify risks or gaps in processes related to CDx development and commercialization.
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Provide deliverables and documentation support for CDx development and validation.
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Develop required clinical validation documentation.
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Create and maintain quality agreement templates between drug sponsors and diagnostic developers.
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Draft SOPs to support the transition from clinical IDE to regulatory submission to commercialization.
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Collaborate cross-functionally to promote compliance and continuous improvement in biomarker/CDx quality systems.
Knowledge & Skills
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Solid understanding of quality principles and applicable regulations related to biomarkers and diagnostics.
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Strong problem-solving and analytical skills.
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Ability to work effectively across functions and with external partners.
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Excellent written and verbal communication skills.
Minimum Qualifications
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Bachelor’s degree in a scientific or allied health discipline.
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Typically requires at least 6 years of relevant experience, or an equivalent combination of education and experience.
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