Global Quality Compliance Lead

Key Responsibilities

• Coordinate and lead GPO, GVO, and GBO Quality Councils; manage agendas, executive analyses, and action tracking.
• Identify cross-functional themes and systemic quality issues; elevate appropriately.
• Partner with QMS Topic Leads and site/OpU leaders to assess risk signals, recurring failure modes, and escalation paths.
• Evaluate red metric trends, commitment-date performance, and recurring issues; influence senior leaders on priorities, resourcing, timelines, and corrective actions.
• Provide oversight of QMS documents and site feedback for QMSC review; align OpU leads to QMS topics.
• Track progress against annual Operating Unit Quality Plans; monitor performance, slippage, dependencies, and resources.
• Lead quality improvement activities from governance, trend analysis, audits/inspections, and leadership reviews.
• Lead/support global critical compliance projects with broad OpU impact.

Required:

• Bachelor’s in Life Sciences, Pharmacy, Chemistry, Engineering, Quality, or related.
• 10+ years in quality/compliance/quality systems/regulated manufacturing.
• Strong QMS governance, risk management, escalation, and quality execution knowledge; strategic analysis and executive communication.

Preferred:

• Experience with quality councils/governance forums.
• CAPA/metric trending/quality plan management/inspection readiness experience; regulated industry experience (e.g., pharma/biotech); global QMS framework knowledge.

• Action item management, compliance activities, data integrity, quality risk management, GMP compliance, QMS, quality metrics, process standardization, progress monitoring, driving continuous improvement.

• Eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits include medical/dental/vision, 401(k), paid holidays, vacation, and sick/compassionate days.