Quality Assurance Documentation Supervisor - Pharmaceutical

Abbott Laboratories seeks a QA Documentation Supervisor to lead quality documentation processes supporting pharmaceutical and diagnostic products. In this role, you'll oversee document control workflows, ensure GMP/GxP-compliant records, and maintain inspection-ready documentation across quality systems. You will supervise a documentation team, coordinate SOP creation and revisions, manage eDMS tools, and support internal/external audits. Collaborating with cross-functional partners, you'll drive process improvements, uphold data integrity, and mentor staff in a mission-driven, innovative, and inclusive environment focused on global health impact.

Responsibilities

• Lead and supervise QA documentation team and daily document control operations
• Maintain GMP/Gx
• P-compliant, inspection-ready documentation and records
• Oversee creation, review, approval, and revision of SOPs and quality documents
• Administer and optimize electronic document management systems (e
• DMS)
• Support internal and external audits with complete, accurate documentation
• Ensure data integrity, version control, and proper archival of records
• Collaborate with QA, manufacturing, regulatory, and R&D stakeholders
• Monitor KPIs and drive continuous improvement in documentation processes
• Train and mentor staff on documentation standards and quality procedures
• Ensure alignment with FDA, EMA, and corporate quality requirements

Required Skills

• GMP/Gx
• P compliance
• Document control systems (e
• DMS)
• Quality management systems (QMS)
• SOP authoring and revision
• Regulatory documentation standards (FDA/EMA)
• Internal audit and inspection readiness
• CAPA documentation and change control
• Data integrity and version control
• MS Office and documentation tools
• Team leadership and training