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Jobs/Quality Control Manager Role/scholarrock - Scholar Rock - Sr. Director, Global Quality Control
scholarrock

scholarrock - Scholar Rock - Sr. Director, Global Quality Control

Cambridge, MA2mo ago
In OfficeDirectorWWPharmaceuticalsBiotechnologyQuality Control ManagerChief Scientific OfficerQuality ControlGovernance

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Requirements

• BS/MS degree in a scientific discipline; advanced degree (MS or PhD) preferred • 15+ years of progressive Quality Control and/or Analytical Sciences experience in biotech/pharma industry (including outsourced operating models), with 7+ years in leadership roles • Deep technical expertise in analytical methods supporting biologics and/or other advanced therapeutic modalities, including release, stability, and characterization testing. • Strong working knowledge of USP, EP, and JP pharmacopeial requirements, and cGMP, ICH guidance, global regulatory requirements, and inspection readiness for outsourced QC operations. • Demonstrated success leading global stability programs, including shelf-life support, data trending, protocol governance, and regulatory commitment execution. • Proven experience in specification development, justification, and lifecycle management, including post-approval specification revisions and change implementation. • Extensive experience with method transfer, qualification, validation, verification, and troubleshooting across contract testing laboratories and manufacturing partners. • Proven ability to lead through influence in a matrixed organization and manage complex external technical relationships with appropriate rigor and accountability. • Strong executive presence, sound scientific judgment, and the ability to balance strategic leadership with practical execution. • Highly proactive, decisive, and capable of independently managing key initiatives. • Engaged people manager committed to building culture as well as mentorship and talent development

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