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QMS Global Quality Compliance Director

Job in Wilmington, New Castle County, Delaware, 19805, USA
Listing for: Merck
Full Time position
Listed on 2026-08-28
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
  • Management
    Regulatory Compliance Specialist
Job Description & How to Apply Below

QMS Global Quality Compliance Director

The QMS Global Quality Compliance Director reports into the AVP, Global QMS and is a senior quality governance and compliance role responsible for driving strategy, execution, and oversight of key quality compliance activities across the Operating Units (OpUs) and associated sites. This role sits on the QMS Leadership team and provides leadership for global quality governance forums, including GPO, GVO, and GBO Quality Councils.

This role serves as a critical connector between site quality teams, OpU leadership, QMS Topic Leads, and global quality governance bodies and Divisional Quality Council (DQC).

The Global Quality Compliance Director is expected to operate with a high degree of autonomy, judgment, and strategic perspective. This role not only coordinates quality council activities, but also interprets quality trends, identifies systemic risks and opportunities, and influences senior leaders to drive timely decisions, remediation, and long-term improvements in quality systems and execution. The position plays an important role in shaping quality strategy, escalating risks appropriately, monitoring execution against annual Quality Plans, and enabling consistent, effective implementation of QMS expectations across the network.

In addition, the Global Quality Compliance Director is responsible for execution of quality improvement activities as identified through governance forums, trend analysis, inspection readiness assessments, leadership reviews, and QMS-related discussions. The role supports simplification, standardization, and continuous improvement efforts that strengthen the overall compliance posture and operational effectiveness of the organization.

Key Responsibilities Strategic Quality Governance and Council Leadership
  • Lead the coordination, administration, and oversight of GPO, GVO, and GBO Quality Councils with a strategic focus on risk, performance, and decision-making.
  • Establish and manage agenda content to ensure councils address critical issues, emerging trends, key decisions, and forward-looking quality priorities.
  • Prepare executive-level analyses, presentations, and summaries that support senior leader review, discussion, and action.
  • Facilitate meeting follow-up, action tracking, and decision documentation to ensure visibility and accountability across responsible functions and sites.
  • Identify cross-functional themes and systemic issues emerging from quality council discussions and elevate them appropriately to leadership forums.
Strategic Risk Identification, Escalation, and Senior Leader Influence
  • Partner with QMS Topic Leads, site quality leaders, and OpU stakeholders to assess risk signals, identify recurring failure modes, and determine appropriate escalation paths.
  • Work closely with the DQC coordinator to ensure that site and OpU risks are evaluated at the correct level before escalation to DQC.
  • Assess red metric trends, commitment-date performance, and recurring issue patterns to determine when risks require leadership intervention and additional visibility.
  • Influence senior leaders across Quality, Operations, and supporting functions to secure alignment on priorities, resourcing, timelines, and corrective actions.
  • Provide clear, fact-based recommendations to leadership regarding risk containment, remediation, and strategic quality decisions.
  • Serve as a trusted escalation point for significant issues affecting QMS implementation, site readiness, or quality execution.
QMS Oversight, Strategy, and Cross-OpU Alignment
  • Provide integrated oversight of QMS documents and site feedback in preparation for QMSC review and approval.
  • Coordinate with each OpU to ensure an appropriate OpU lead is assigned for each QMS topic submitted to QMSC.
  • Identify implementation challenges, complexity drivers, and site concerns associated with QMS updates and translate them into actionable leadership insights.
  • Recommend opportunities for standardization, simplification, and harmonization of QMS processes across OpUs.
  • Support strategic alignment between global QMS expectations and local execution realities to improve adoption and sustainability.
  • Act as an escalation point…
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