Global Quality Compliance Lead

Job Summary / Key Responsibilities

• Lead coordination, administration, and oversight of GPO, GVO, and GBO Quality Councils; set agendas, prepare executive summaries, track actions, and identify systemic themes.
• Partner with Topic Leads and site leaders to assess risk signals, recurring failure modes, escalation paths, and red-metric/commitment-date performance; provide fact-based recommendations and serve as escalation point.
• Provide integrated oversight of QMS documents and site feedback for QMSC review; coordinate OpU topic leads; translate QMS update challenges into leadership insights; promote standardization/simplification/harmonization.
• Own tracking and oversight of progress against the annual Quality Plan; monitor performance, slippage/dependencies/resource constraints; provide periodic governance updates.
• Lead quality improvement activities from councils/trends/audits/inspections/leadership reviews; define scope and success measures; drive cross-functional execution and track effectiveness; support site readiness, inspection performance, and process consistency.
• Lead/support global critical compliance projects; develop plans/governance, monitor progress, communicate status, and ensure sustainable implementation.

• Required:
  
  Bachelor’s in Life Sciences/Pharmacy/Chemistry/Engineering/Quality (or related); 10+ years in quality/compliance/quality systems/regulated manufacturing; strong QMS governance and risk/escalation knowledge; ability to analyze complex quality data and translate to action; influence senior leaders cross-functionally; executive communication; manage priorities/ambiguity.
• Preferred: experience with quality councils/governance forums; quality improvement/standardization/compliance transformation; CAPA/metric trending/quality plan management/inspection readiness; pharma/biotech (highly regulated) experience; global QMS frameworks across multi-site orgs.

• Quality Management Systems (QMS), quality risk management, GMP/regulatory compliance, continuous improvement, data integrity, process standardization/improvement, executive leadership, performance plan/progress monitoring, compliance activities.

• Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.