What are the responsibilities and job description for the Global Operational Quality Specialist position at SoTalent?
Global Quality Systems & Operational Excellence Specialist
Location: Greenwood, SC
Work Arrangement: Full-time
Travel: Up to 10%
Role Overview
An opportunity is available for an experienced quality professional to drive consistent Quality Assurance and Quality Control practices across a global biopharmaceutical manufacturing network. This role focuses on quality governance, harmonisation of standards, quality systems, regulatory compliance, and continuous improvement across multiple sites.
Working closely with global and site-level teams, the successful candidate will strengthen quality performance, inspection readiness, and operational excellence through effective governance, data-driven decision-making, and cross-functional collaboration.
Key Responsibilities
- Develop and maintain global quality governance frameworks, including governance structures, KPI/KQI frameworks, reporting processes, and inspection-readiness measures.
- Coordinate quality escalations, oversee CAPA governance and effectiveness, and follow up on critical quality events, operational issues, and cross-site risks.
- Coordinate the Global Quality Plan, Annual Product Reviews, Management Reviews, and strategic quality initiatives.
- Drive global quality culture and excellence programmes, promoting communication, knowledge sharing, and best-practice implementation.
- Develop and improve global QA/QC standards, corporate SOPs, product release frameworks, control strategies, and quality oversight models.
- Lead quality harmonisation initiatives, including gap assessments, implementation tracking, and alignment of standards across sites.
- Maintain the global GxP training framework, covering training governance, curricula, effectiveness, and Learning Management System processes.
- Establish investigation principles, promote robust root cause analysis, and define expectations for CAPA effectiveness.
- Lead global quality change management, including impact assessments and implementation across multiple sites.
- Support strategic business initiatives through quality expertise, process optimisation, digitalisation, and continuous improvement.
Requirements
- MSc in Pharmacy, Biotechnology, Bioengineering, Engineering, Life Sciences, or a related scientific or technical discipline.
- At least 10 years of experience in a GMP-regulated environment, including global quality systems, operational QA/QC, quality governance, and cross-site initiatives.
- Strong technical knowledge of GMP, Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), product testing and release, validation, data integrity, CAPA, change management, and regulatory requirements.
- Proven experience developing and implementing global quality standards, governance frameworks, and harmonised operational processes.
- Strong analytical and digital skills, including KPI/KQI development, trend analysis, SharePoint, reporting dashboards, and automation tools.
- Excellent stakeholder management, communication, and coordination skills, with the ability to influence global QA, QC, Operations, Validation, and senior leadership teams.
- Willingness to travel up to 10%.