Senior Director, Head of Global Data Management and Standards (GDMS) Process & Quality Management - Hybrid

MSD • Rahway, PA

1d • Hybrid

About The Position

The Sr. Director and Head of GDMS Process and Quality Management is responsible for the development, implementation, oversight, and maintenance of the GDMS process and training compliance framework; business processes; associated functional process training; and quality management activities. Reporting to the Head of Global Data Management and Standards, sets the vision for the organization and is responsible for the timely and quality delivery of GDMS Process & Quality Management services.

Requirements

• Bachelor’s degree in life sciences, medicine, pharmacy, nursing, health informatics, or other 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 experience and demonstrated success in personnel management, including direct line management of managers or program managers in a matrixed, global organization.
• Experience managing, overseeing, and improving clinical data management processes across the full lifecycle (planning, start-up, conduct, close-out, archival).
• Experience preparing, leading and guiding program and study teams through audits, inspections, and CAPA management activities across therapeutic areas.
• Experience with using and/or managing data management and clinical trial technologies including those used by sponsors and vendors.
• Demonstrated 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
• Well-versed in ICH-GCP and other regulatory requirements with particular focus on their application to clinical data management
• Familiarity with regulations in different countries (eg., FDA, EMA, MHRA, PMDA, Health Canada, and emerging markets)
• Working knowledge of risk-based approaches to clinical data management and adjacent clinical operations processes (ex., RBQM)
• Strong analytical and problem-solving ability with a pragmatic approach to balancing quality, compliance, timelines, and cost
• High integrity and a compliance-focused mindset
• Outstanding written and verbal communication skills, including ability to translate complex concepts into clear, concise, and actionable communications for non‑technical executives and cross‑functional stakeholders

Nice To Haves

• Professional training or certification in clinical research and/or data management relevant disciplines including but not limited to: Association of Clinical Research Professional (ACRP) certification; SCDM Clinical Data Manager (CCDM) certification
• Professional training or certification in quality management, business process management, or Lean Six Sigma (eg., ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Auditor (CQA), Lean Six Sigma black/green belt
• Data Quality Management
• Process Management
• Project Management
• Quality Management
• Vendor Quality Management

Responsibilities

• Establishes and maintains the GDMS Process & Quality Management operating model, governance cadence, priorities, decision rights, and escalation pathways to drive consistent execution and accountability
• Serves as the Process Owner (PO) for all GDMS processes, oversights GDMS process development and maintenance, and directs the network of GDMS Sub- Process Owners (SPO) to ensure that business processes are effectively coordinated and aligned
• Partners with GDMS Business Operations and other stakeholders to align functional training strategy with process requirements and role expectations
• Ensures that GDMS process documentation and associated functional training is complete, aligned, of high quality, and compliant with regulatory requirements
• Ensures process changes are assessed for impact to documentation, role expectations, functional training requirements, and inspection readiness
• Engages with clinical programs and clinical trial teams to resolve escalated GDMS quality and compliance issues that are unable to be resolved at lower levels within the organization
• Serves as primary GDMS point of contact for audits and inspections, oversees GDMS responses, and ensures timely and effective CAPA management
• Serves as the "Center of Excellence" (COE) for business process management ensuring that inspection, audit, CAPA, and quality issue learnings are translated into sustainable process, training, documentation, and capability improvements
• Develops and monitors performance metrics, trends, and risk indicators to assess effectiveness, identify capability gaps, and drive continuous improvement
• Proactively engages with stakeholders, functional area leaders, quality and compliance organizations, and regulatory inspectors, ensuring that GDMS maintains high quality and complaint performance
• As a member of the GDMS Leadership team, actively contributes to organizational strategy, planning, and transformation
• Strategy development, planning, and alignment with organizational goals and priorities
• Resource forecasting and management to ensure portfolio and other organizational objectives are met
• Leadership of talent development and performance management activities with a focus on building a high-performing team and fostering a culture of growth and development
• Oversight of financial forecasting, budget, and expense management
• Leadership engagement with internal stakeholders and industry leaders to identify opportunities for innovation and continuous improvement
• Ensuring process alignment with regulatory expectations and industry best practice
• Ensuring organizational awareness and compliance with company policies, procedures, mandatory training, and regulatory requirements (i.e., ICH, GCP)
• Sponsorship and/or leadership of organizational initiatives

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus and long-term incentive, if applicable

What This Job Offers

• Job Type: Full-time
• Career Level: Director