Global Development Quality Management (GCP) - Contract - New York
Are you looking to make an impact with your innovation? We are working with a well-established pharmaceutical company to recruit for a manager of Global Development Quality!
Proclinical is seeking a Quality Management Lead (GCP) to provide leadership and guidance on quality and compliance within Global Development Quality systems.
Primary Responsibilities:
In this role, you will collaborate with study teams and cross-functional stakeholders to run risk-based quality management activities for clinical trials, making certain of inspection readiness and addressing quality issues proactively.
Skills & Requirements:
- Strong knowledge and application of GCP guidelines, including managing complex quality issues and compliance activities.
- Expertise in proactive quality management, risk assessment, and providing GCP consultancy to stakeholders.
- Experience in risk-based approaches to quality management and developing fit-for-purpose quality processes.
- Familiarity with regulatory agency inspections and serving as a Subject Matter Expert during such processes.
- Bachelor's degree in a relevant field.
- Background in quality/compliance roles or clinical development with transferable skills related to GCP/GVP.
The Global Development Quality Management's responsibilities will be:
- Be a Subject Matter Expert to advise on quality issues and ensure compliance.
- Lead Risk-Based Quality Management (RBQM) initiatives and process improvements in collaboration with functional areas.
- Manage GCP-compliant activities from a quality perspective alongside the business and GDQM GCP team.
- Provide day-to-day support for issue management, audit responses, CAPA oversight, and proactive quality management.
- Oversee Quality Risk Management activities for clinical trials within assigned studies.
- Facilitate Quality Risk Assessment and Control Tracker (QRACT) activities during protocol development based on ICH E6 R2 guidelines.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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