Director of Client Management
4 weeks ago
Job Title: Associate Director, Client Management
Job Summary:
We are seeking an experienced Associate Director to lead our Client Management team. The successful candidate will be responsible for managing inspection readiness across various clinical study teams, ensuring compliance with regulatory requirements, guidelines, laws, and internal standards.
Key Responsibilities:
- Supervising and managing activities for inspection readiness, leading inspections from regulatory authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
- Collaboration across cross-functional teams to ensure unified approaches to inspection readiness strategies.
- During inspections, assigning inspection requests to appropriate subject matter experts (SMEs), and providing guidance to ensure timely fulfillment.
- Writing and updating SOPs and tools for inspection readiness and management.
- Implementing and maintaining QA systems, such as investigations, deviations, CAPAs, and significant quality events (SQEs).
- Support and manage pre-inspection visits at investigative sites.
- Fulfil all inspection commitments, respond to inspections, and conduct post-inspection activities, CAPAs, and resolve issues for timely closure.
- Manage a central repository of global inspection status and updates.
Requirements:
- At least 7-10 years of experience in GCP-related QA functions in the pharmaceutical, biotechnology, or related health care industries.
- Extensive understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries.
- Proven ability to set strategies and driving initiatives for improving quality processes.
- Demonstrated leadership skills and ability to mentor others.
About Cpl Healthcare:
Cpl Healthcare is a leading provider of healthcare recruitment solutions. We are committed to delivering exceptional service and expertise to our clients and candidates.
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