Quality Compliance Specialist

A company is looking for a Quality Compliance Specialist to oversee clinical trial delivery quality systems and ensure compliance with regulations.

Key Responsibilities

Lead the clinical trial delivery system inspection readiness program and engage with relevant functions to ensure accountability and transparency

Host GCP inspections and manage inspection response activities, ensuring timely and adequate responses

Act as Subject Matter Expert on Clinical Quality Compliance activities, leading complex quality investigations and managing CAPA development

Required Qualifications

BSc in a scientific or allied health / medical field (or equivalent degree)

Minimum of 7 years of relevant experience in the pharmaceutical industry, including at least 3 years in GCP Quality / Compliance

Advanced knowledge of pharmaceutical development and GCP / GVP regulations

Experience in developing and implementing clinical audit programs and leading regulatory inspections

Skilled in managing global, cross-functional projects