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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.
Position SummaryThe GLP Operational Quality Manager supports quality oversight for GLP-related processes and activities. This role involves partnering with stakeholders to drive quality outcomes and operational excellence, while ensuring compliance, readiness for future needs, and continuous improvement of quality systems. The individual will also work with quality analytics to develop meaningful indicators that enable ongoing evaluation of system health and risk identification.
Key Responsibilities
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Support GLP Operational Quality and business partners in achieving quality outcomes and operational excellence.
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Ensure compliance and maximize the impact of quality oversight activities.
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Collaborate with quality analytics to design quality indicators for evaluating processes, systems, and risk.
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Partner with R&D quality colleagues to promote scalable and consistent approaches across products and programs.
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Review regulatory documents (e.g., Investigator Brochures, INDs, BLAs, NDAs) to identify potential risks or gaps.
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Provide input on vendor audit scope and focus.
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Conduct proactive inspection readiness activities, including quality assessments of GLP studies (on-site or remote).
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Develop and track metrics related to GLP activities with preclinical and quality stakeholders.
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Contribute to content development and delivery for annual GLP refresher training.
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Perform additional duties as assigned.
Requirements
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Bachelor’s degree or equivalent in a related scientific field.
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Strong experience in GLP, including reviewing data and documents supporting GLP studies and submissions.
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Background in the pharmaceutical or contract research organization (CRO) environment.
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RQAP-GLP certification preferred but not required.
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Ability to work independently, prioritize, and meet deadlines in a fast-paced setting.
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Excellent communication and collaboration skills.
Travel Requirements
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Up to 20% travel may be required, primarily to CROs for quality reviews of data.
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Occasional travel to headquarters or training sites may also be required
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