More jobs:
Manager, GD; Global Development) Quality Management
Job in
Elizabeth, Union County, New Jersey, 07215, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Role:
Manager, Process & Personnel Qualification Management Expert in R&D Quality, focusing on driving compliance and quality excellence within pharmaceutical development.
- lead process improvement projects including process mapping, training development, and qualification;
- act as a key quality partner for Global Development, ensuring GxP Quality Framework adapts to regulatory and business changes;
- support digital transformation initiatives to establish data-centric qualification systems;
- manage project timelines, risks, issues, and stakeholder communication;
- potentially lead audits and inspections.
- Bachelor's in Science or Business (Master's preferred);
- at least 5 years of experience in pharmaceutical/device compliance within a matrix organization;
- strong knowledge of global clinical safety, pharmacovigilance, and regulatory standards;
- excellent communication, project management, and analytical skills;
- proven leadership and collaboration abilities.
- Business Process Management, SOP development, quality standards (ISO 9001), and process optimization.
High-Value: pharmaceutical compliance, process development, digital transformation, GxP frameworks, global development, audits, and inspections.
Work setup: likely hybrid or remote with international scope.
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