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Director of GCP Process Excellence
A company is looking for a Director of GCP Process Excellence. Key Responsibilities Oversee compliance and strategic direction for the Quality Management System (QMS) and Standard Operating Procedure (SOP) development for clinical trial delivery Collaborate with various stakeholders to ensure effective implementation of end-to-end processes and continuous improvement initiatives Facilitate the Business Process Owner (BPO) and Business System Owner (BSO) Network to ensure consistency in clinical trial delivery processes Required Qualifications and Education BS, MS or equivalent degree Minimum of 10+ years of experience in the pharmaceutical, CRO, healthcare, or related industry At least 5+ years of experience with QMS and process development for clinical trial delivery Deep knowledge of clinical trial delivery operations and lifecycle, along with US CFR, GCP, and ICH regulations Experience in stakeholder relationship management and working in a matrix organization
A company is looking for a Director of GCP Process Excellence.
Key Responsibilities
Oversee compliance and strategic direction for the Quality Management System (QMS) and Standard Operating Procedure (SOP) development for clinical trial delivery
Collaborate with various stakeholders to ensure effective implementation of end-to-end processes and continuous improvement initiatives
Facilitate the Business Process Owner (BPO) and Business System Owner (BSO) Network to ensure consistency in clinical trial delivery processes
Required Qualifications and Education
BS, MS or equivalent degree
Minimum of 10+ years of experience in the pharmaceutical, CRO, healthcare, or related industry
At least 5+ years of experience with QMS and process development for clinical trial delivery
Deep knowledge of clinical trial delivery operations and lifecycle, along with US CFR, GCP, and ICH regulations
Experience in stakeholder relationship management and working in a matrix organization