Global Quality Compliance Lead
Job in
Durham, Durham County, North Carolina, 27703, USA
Listed on 2026-09-18
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-18
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Job Summary
- Drive strategy, execution, and oversight of global quality compliance activities across Operating Units (OpUs) and sites.
- Lead global quality governance forums (GPO, GVO, GBO Quality Councils) and connect site teams, OpU leadership, QMS Topic Leads, and governance bodies.
- Lead council coordination, agenda planning, executive analyses, and action tracking; identify cross-functional themes and systemic issues.
- Identify risks from quality trends/metrics, determine escalation paths (incl. DQC), and provide fact-based recommendations to senior leaders.
- Oversee QMS documents and site feedback for QMSC review/approval; support standardization/simplification across OpUs.
- Own annual Quality Plan progress tracking; monitoring delivery risks, slippage, dependencies, and resources.
- Lead quality improvement execution from councils/trends/audits/inspections; define scope and success measures; monitor effectiveness.
- Lead/support global critical compliance projects; establish plans, governance, ownership, follow-up, and metrics.
- Required:
BS/BA in Life Sciences/Pharmacy/Chemistry/Engineering/Quality (or related); 10+ years quality/compliance/QMS/regulated manufacturing; strong QMS governance & risk/escalation understanding; strategic analysis and action; proven ability to influence senior leaders without authority; executive communication; manage ambiguity and multiple priorities. - Preferred: experience with quality councils/governance forums; quality improvement/standardization/compliance transformation; CAPA & metric trending/inspection readiness; pharma/biotech or highly regulated industry; global QMS framework knowledge.
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