Description

You will manage the QUMAS Compliance Platform to centralize quality and regulatory initiatives within the Life Sciences sector.

Responsibilities

• Administer Document and Quality Management solutions, including SOPs, QA documents, CAPA, Deviation, Change Control, and Audit processes.
• Execute document migration, regulatory submissions, training, and collaboration tasks within a single interface.
• Support regulatory affairs through submission management, eCTD authoring templates, and document migration from legacy systems.
• Maintain compliance standards using electronic signatures, audit trails, and role-based permissions.

Required Skills

• 10+ years of hands-on experience with QUMAS.
• Deep knowledge of FDA 21 CFR Part 11 requirements and Life Sciences regulatory compliance.
• Experience managing Electronic Document Management and GMP Compliance.
• Proficiency with SQL.
• Experience with Documentum.
• Experience with Oracle.
• Familiarity with SharePoint 2010 and controlled access protocols.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Gradute