Clinical Quality Compliance Specialist

A company is looking for a Clinical Quality Compliance Specialist.

Key Responsibilities

Develop and implement GCP Compliance strategies while managing operational activities within the GCP Compliance function

Host GCP inspections and provide strategic direction to relevant functions and Subject Matter Experts (SME)

Oversee the completion and closure of inspection CAPAs, ensuring timely mitigation of risks and effectiveness checks

Required Qualifications

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

Advanced knowledge of pharmaceutical development and GCP / GVP regulations (FDA, EU, MHRA, PMDA, ICH)

Experience in managing operational and compliance metrics, as well as quality inspection risks

Ability to develop and monitor Key Performance / Quality Indicators (KPI / KQI)

Local to Cambridge, MA, with the ability to work onsite 2-3 days a week