Associate Director GCP Quality Assurance EMEA

Job title:

Company

SciPro

Job description

SciPro is proud to be partnered with a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases.Summary:We are seeking an Associate Director of Clinical Quality Assurance (CQA) for the EMEA region. Reporting to the Sr. Director of CQA, you will be the GCP Subject Matter Expert (SME) for EMEA, ensuring quality and regulatory compliance across clinical operations.Key Responsibilities:

Act as the GCP and EMEA regulation SME.
Support and maintain a risk-based quality system.
Develop and implement strategic audit plans.
Conduct audits of investigator sites, vendors, and internal processes.
Guide and evaluate vendors for quality and compliance.
Collaborate cross-functionally to address GCP quality issues.
Ensure compliance with ICH E6 GCP guidelines.
Manage quality documentation in Veeva QMS and Vault.
Represent the company during regulatory inspections.

Requirements:

BS in Biology, Chemistry, or related life sciences (MS, PhD, MBA preferred).
7-10 years of experience in clinical quality assurance.
Experience with regulatory inspections and biologics preferred.
Strong GCP audit experience and knowledge of EU clinical regulations.
Ability to travel domestically and internationally (25-30%).

Join us to make a meaningful impact in the biopharmaceutical industry. Apply today!ApplyOther roles you might
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