QMS Global Quality Compliance Director

QMS Global Quality Compliance Director

The QMS Global Quality Compliance Director reports into the Associate Vice President, 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 for major concerns raised by sites or OpU Topic Leads related to implementation of QMS changes.

Quality Plan Execution and Performance Management

• Own tracking and oversight of progress against the annual Quality Plan for the Operating Units.
• Work with OpU Heads, Objective Owners, and key stakeholders to monitor performance, identify delivery risks, and ensure progress remains aligned to plan.
• Prepare and present periodic status updates for OpU Quality Councils and other governance forums as required.
• Identify slippage, dependencies, and resource constraints that may impact delivery and work with leaders to drive resolution.
• Support the translation of quality strategy into measurable actions, milestones, and governance routines.

Execution of Quality Improvement Activities

• Lead execution of quality improvement activities identified through councils, trend analysis, audits, inspections, leadership reviews, or QMS discussions.
• Partner with relevant stakeholders to define improvement scopes, objectives, deliverables, and success measures.
• Drive cross-functional execution of improvement actions, ensuring accountability, timelines, and outcome tracking.
• Monitor the effectiveness of improvement actions and elevate barriers to completion or sustainability.
• Contribute to building a culture of continuous improvement by identifying opportunities to reduce complexity, improve effectiveness, and enhance compliance performance.
• Support or lead targeted initiatives that improve site readiness, governance effectiveness, inspection performance, and process consistency.

Global Compliance Projects and Organizational Impact

• Lead or support global critical compliance projects that have broad impact across all OpUs and materially improve compliance posture.
• Manage initiatives that require coordination across functions, geographies, and leadership levels.
• Develop project plans, establish governance, monitor progress, and communicate status to senior stakeholders.
• Ensure sustainable implementation of improvements through clear ownership, follow-up, and metrics-based monitoring.
• Contribute to long-term capability building and maturity of quality governance and execution across the organization.

Qualifications

Required

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Engineering, Quality, or a related discipline.
• Extensive experience (minimum 10 years) in quality, compliance, quality systems, or regulated manufacturing environments.
• Strong understanding of QMS governance, risk management, escalation processes, and quality execution expectations.
• Demonstrated ability to develop strategy, analyze complex quality data, and translate insights into action.
• Proven track record of influencing and collaborating with senior leaders and cross-functional stakeholders without direct authority.
• Strong executive communication skills, including the ability to present complex information clearly and concisely.
• Demonstrated ability to lead multiple priorities, manage ambiguity, and drive accountability across global teams.

Preferred

• Experience supporting or leading quality councils, governance bodies, or executive review forums.
• Experience in driving quality improvement initiatives, standardization efforts, or compliance transformation programs.
• Familiarity with CAPA, metric trending, quality plan management, and inspection readiness processes.
• Experience in pharmaceutical, biotechnology, or other highly regulated industries.
• Knowledge of global QMS frameworks and their application across multi-site organizations.

Required Skills:

Action Item Management, Compliance Activities, Coordinating Resources, Customer-Focused, Data Integrity, Driving Continuous Improvement, Efficiency Improvements, Executive Leadership, Executive Presence, Global Coordination, GMP Compliance, Innovation, Mentoring Staff, Operational Quality, Performance Plans, Pharmaceutical Quality Control (QC), Process Improvements, Process Standardization, Progress Monitoring, Quality Control Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Management, Regulatory Compliance {+ 3 more}

Preferred Skills: