This listing was posted on Manatal ATS.
Associate Director, Global GCP
Location:
London, Gt Lon
Description:
We are looking for an experienced candidate who will be responsible for GCP inspection readiness across various clinical study teams. The role will include management of inspection logistics and process improvements for ensuring RD activities are compliant with regulatory requirements, guidelines, laws and internally established 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.Qualifications and Experience: 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. Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Please use the below Lifelancer link for job application and quicker response. https://lifelancer.com/jobs/view/27da495bd57764f64345283cec836a2b
Company:
Lifelancer
Posted:
October 16 on Manatal ATS
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to Manatal ATS
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.