Senior Director, Head of Global Data Management and Standards – Process & Quality Management

MSD

. Develop, implement, oversee, and maintain the GDMS process and training compliance framework, business processes, functional process training, and quality management activities .

Posted 10/6/2026full-timeUnited StatesSenior💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Data Management and Quality Management processes, with a strong focus on compliance, regulatory requirements, and continuous improvement. Proven ability to lead teams, manage audits, and develop strategic initiatives within the pharmaceutical or biotech industry.

Highest-signal resume keywords

Clinical Data ManagementQuality Management OperationsAudit InspectionsRegulatory CompliancePeople Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data ManagementGood Clinical Practice (GCP)Good Clinical Data Management Practice (GCDMP)Lean Continuous ImprovementRisk-Based ApproachesClinical Trial TechnologiesProcess ImprovementPerformance Metrics DevelopmentCAPA ManagementClinical Development Knowledge

Soft Skills

Analytical Problem-SolvingStrategic ThinkingAdaptabilityOutstanding CommunicationHigh Integrity

Industry Keywords

Pharmaceutical IndustryBiotech IndustryICH-GCPFDA RegulationsEMA RegulationsMHRA RegulationsPMDA RegulationsHealth Canada RegulationsClinical Trial OperationsClinical Data Standards

About the role

Key responsibilities & impact

Develop, implement, oversee, and maintain the GDMS process and training compliance framework, business processes, functional process training, and quality management activities
Set the vision for GDMS Process & Quality Management and ensure timely, high-quality service delivery
Establish and maintain the operating model, governance cadence, priorities, decision rights, and escalation pathways
Serve as Process Owner for all GDMS processes and direct the network of GDMS Sub-Process Owners
Align functional training strategy with process requirements and role expectations
Ensure process documentation and functional training are complete, high quality, and compliant with regulatory requirements
Assess process changes for impacts on documentation, role expectations, training requirements, and inspection readiness
Resolve escalated GDMS quality and compliance issues with clinical programs and clinical trial teams
Serve as primary GDMS point of contact for audits and inspections; oversee responses and CAPA management
Lead the Center of Excellence for business process management and translate audit, inspection, CAPA, and quality learnings into sustainable improvements
Develop and monitor performance metrics, trends, and risk indicators
Engage stakeholders, functional leaders, quality and compliance organizations, and regulatory inspectors
Contribute to GDMS organizational strategy, planning, and transformation
Lead strategy development, resource forecasting, talent development, performance management, financial forecasting, budgeting, and expense management
Sponsor or lead organizational initiatives and identify opportunities for innovation and continuous improvement

Requirements

What you’ll need

Bachelor’s degree in life sciences, medicine, pharmacy, nursing, health informatics, or another healthcare-related field
10+ years in clinical data management within the pharmaceutical or biotech industry
5+ years directing or managing process and quality management operations
5+ years of personnel management, including direct line management of managers or program managers in a matrixed, global organization
Experience managing and improving clinical data management processes across the full lifecycle
Experience preparing, leading, and guiding program and study teams through audits, inspections, and CAPA management across therapeutic areas
Experience using or managing data management and clinical trial technologies used by sponsors and vendors
Knowledge of clinical development, clinical trial operations, clinical data management, and quality management processes
Knowledge of clinical data standards and their use in clinical data management
Working knowledge of ICH-GCP and other regulatory requirements
Familiarity with FDA, EMA, MHRA, PMDA, Health Canada, and emerging-market regulations
Working knowledge of risk-based approaches to clinical data management and adjacent clinical operations processes, such as RBQM
Strong analytical and problem-solving ability
High integrity and compliance-focused mindset
Outstanding written and verbal communication skills
Required skills: Adaptability, Audit Inspections, Clinical Data Management, Ethical Standards, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Lean Continuous Improvement, People Leadership, Strategic Thinking, Team Leadership
Visa sponsorship available

Benefits

Comp & perks

Annual bonus eligibility
Long-term incentive eligibility, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Hybrid work arrangement
Visa sponsorship
10% travel