Global Quality Compliance Lead

Job Summary

• Drive strategy, execution, and oversight of key quality compliance activities across Operating Units (OpUs) and associated sites.
• Provide leadership for global quality governance forums (GPO, GVO, GBO Quality Councils) and act as a connector between site quality teams, OpU leadership, QMS Topic Leads, and global governance bodies/DQC.
• Operate autonomously to interpret quality trends, identify systemic risks/opportunities, escalating appropriately, monitor execution against annual Quality Plans, and enable consistent implementation of QMS expectations.
• Lead quality improvement activities identified via governance forums, trend analysis, inspection readiness assessments, leadership reviews, and QMS discussions.

• Lead coordination/administration/oversight of GPO, GVO, GBO Quality Councils; manage agendas; prepare executive analyses; track actions and decisions; identify themes and systemic issues.
• Identify risks and recurring failure modes; coordinate escalation with DQC; assess red metrics/commitment-date performance; influence senior leaders; provide fact-based recommendations; serve as trusted escalation point.
• Oversee QMS documents and site feedback for QMSC review; ensure OpU topic leads assigned; translate QMS update challenges into leadership insights; recommend standardization/simplification/harmonization; escalated major implementation concerns.
• Own tracking of progress against annual Quality Plans; monitor performance and delivery risks; provide status updates; identify slippage/dependencies/resource constraints; translate quality strategy into actions/milestones.
• Execute quality improvement actions; define scope/objectives/deliverables/success measures; drive cross-functional accountability and tracking; monitor effectiveness; support continuous improvement and targeted initiatives.
• Lead/support global critical compliance projects; develop plans/governance; monitor and communicate progress; ensure sustainable implementation via ownership/follow-up/metrics; build long-term capability.

• Required
  • Bachelor’s in Life Sciences, Pharmacy, Chemistry, Engineering, Quality, or related.
  • 10+ years in quality, compliance, quality systems, or regulated manufacturing.
  • Strong understanding of QMS governance, risk management, escalation, and quality execution expectations.
  • Ability to develop strategy, analyze complex quality data, and translate insights into action.
  • Proven record influencing senior leaders and cross-functional stakeholders without direct authority.
  • Strong executive communication; ability to lead multiple priorities in ambiguity and drive global accountability.
• Preferred
  • Experience supporting/leading quality councils/governance/executive review forums.
  • Experience driving quality improvement, standardization, or compliance transformation.
  • Familiarity with CAPA, metric trending, quality plan management, inspection readiness.
  • Pharmaceutical/biotech or other highly regulated industry experience.
  • Knowledge of global QMS frameworks across multi-site organizations.

• Action item management; compliance activities; data integrity; driving continuous improvement/efficiency improvements; executive leadership/presence; global coordination; GMP compliance; mentoring staff; operational quality; performance plans; QMS; quality metrics/risk management; regulatory compliance; process improvements/standardization; progress monitoring; quality control/management.

• Annual bonus and long-term incentive (if applicable).