QMS Global Quality Compliance Director

Key Responsibilities

• Lead coordination, administration, and oversight of GPO, GVO, and GBO Quality Councils; manage agendas; prepare executive analyses; track actions and decisions; identify systemic themes and elevate.
• Partner to assess quality risk signals and recurring failure modes; ensure correct escalation to DQC; use red-metric trends/commitment-date performance to determine leadership intervention; influence senior leaders; provide fact-based recommendations; act as escalation point for major QMS/site readiness/quality execution issues.
• Provide integrated oversight of QMS documents for QMSC review; coordinate OpU assignment for QMS topics; translate QMS update challenges into leadership insights; recommend standardization/simplification/harmonization; elevate major implementation concerns.
• Own tracking of annual Operating Unit Quality Plan progress; monitor performance, slippage, dependencies, and resources; provide status updates.
• Lead execution of quality improvement activities from councils/trends/audits/inspections/leadership reviews; define scope/objectives/success measures; drive cross-functional execution and monitor effectiveness.
• Lead/support global critical compliance projects; manage cross-function/geography initiatives; establish governance, plans, and metrics.

• 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/escalation understanding; ability to analyze complex quality data and turn insights into action; proven senior stakeholder influence without direct authority; strong executive communication; global, ambiguity-tolerant priority management.
• Preferred:
  Quality council/governance forum experience; quality improvement/standardization/compliance transformation; CAPA/metric trending/quality plan/inspection readiness familiarity; pharma/biotech regulated experience; global QMS frameworks.

• Action item management, compliance activities, QMS, quality metrics & risk management, GMP compliance, executive leadership/presence, global coordination, continuous improvement, data integrity, performance plan/progress monitoring, process standardization & improvement.

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