Senior Regulatory -Subject Matter Expert (Laboratory Operations)

Position Summary:

We are seeking an experienced Senior Regulatory / GMP Subject Matter Expert (SME) to support laboratory quality and compliance initiatives within a regulated pharmaceutical, biotechnology, or life sciences environment. The ideal candidate will possess extensive knowledge of GMP regulations, laboratory quality systems, regulatory expectations, and remediation programs. This role will be responsible for assessing current laboratory practices, identifying compliance gaps, developing corrective action strategies, and overseeing implementation activities to ensure regulatory readiness and operational excellence.

Key Responsibilities:

• Establish and maintain a documented surveillance process to monitor laboratory compliance with GMP regulations, internal procedures, and industry best practices.
• Conduct comprehensive gap assessments of existing Quality Control (QC) laboratory methods, processes, procedures, systems...