Senior Manager, GCP Quality Assurance (Cambridge)

Employment Type

: Full-Time


: Non-Executive Management

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In conjunction with QA Management and staff, assist in creating, implementing and maintaining an efficient, phase-appropriate and compliant GCP systems;

Partner with stakeholders to develop GCP SOPs, policies and procedures consistent with corporate objectives;

Provide QA Support for CRO oversight:

o Represent Stealth QA on Sponsor/CRO/Site project calls and provide updates to QA Management;

o Provide QA support for critical quality issues, protocol deviations and investigations;

Provide QA/QC review of protocols, CSRs, and other Clinical and Regulatory documentation as needed;

Assist in the development and implementation of GCP training programs and conduct training sessions as required;

Assist in the coordination and oversight of internal and external GCP audits;

Proactively identify potential quality issues/discrepancies and work with QA Management to effectively resolve in a compliant and timely manner;

Research changes and updates to ICH, GCP regulations;

Assist in the preparation and coordination of Material View Board (MRB) meetings, as needed;

Perform disposition activities for clinical trial drug substance and drug product, as needed

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