Associate Director, Global GCP

Remote, with occasional travelling required

Full time, permanent

Overview: 

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 R&D 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. 

If interested, please send your CV to