Global Operational Quality Specialist

Location: US - Greenwood, SC; willingness to travel up to 10%

Company

hirify.global operates in the life sciences and biotechnology sector.

What you will do

• Define and maintain global quality governance models, KPI/KQI frameworks, reporting processes, and inspection-ready performance management.
• Coordinate escalation processes, CAPA governance, critical quality events, cross-site risks, and operational QA/QC issues.
• Coordinate Global Quality Plans, Annual Product Reviews, Management Reviews, and strategic quality initiatives.
• Develop and implement global QA/QC standards, SOPs, product release frameworks, control strategies, and quality oversight models.
• Drive harmonization through gap assessments, implementation follow-up, quality culture programs, and best-practice sharing.
• Maintain GxP training, change management, investigation, digitalization, and continuous improvement programs across sites.

Requirements

• MSc in Pharmacy, Biotechnology, Bio-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 and cross-site quality initiatives.
• Technical expertise in GMP, QMS, LIMS, product testing and release, validation, data integrity, inspection readiness, CAPA, and change management.
• Experience developing and harmonizing global quality standards, governance frameworks, and operational quality processes.
• Strong analytical and digital capabilities, including KPI/KQI development, trend analysis, SharePoint, dashboards, and automation tools.
• Excellent coordination, stakeholder management, and communication skills across QA, QC, Operations, Validation, and senior leadership.

Culture & Benefits

• Cross-functional collaboration with global and site quality teams.
• Global knowledge sharing and quality culture initiatives across sites.
• Opportunity to support process optimization, digitalization, and operational excellence.
• Travel of up to 10% is expected.