Global Data Management & Quality Transformation Leader

MSD Malaysia

North Wales (Montgomery County)

Hybrid

USD 173,000 - 273,000

Full time

5 days ago
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
401(k)
Paid holidays
Vacation
Sick days

Job summary

Merck & Co. in the United States is seeking a Sr. Director and Head of GDMS Process & Quality Management to lead the development, implementation, and oversight of the GDMS framework and related training & quality activities.

This executive role reports to the Head of Global Data Management & Standards and sets the vision for GDMS, ensuring timely, high-quality delivery of services and regulatory compliance across the organization.

Qualifications

  • Bachelor’s degree in life sciences, medicine, pharmacy, nursing, health informatics, or related field.
  • Preferred: professional training or certification in clinical research/data management.
  • Professional training/certification in quality or process management (CMQ/OE, CQA, Lean Six Sigma).

Responsibilities

  • Establishes and maintains governance cadence, operating model, and escalation pathways for GDMS Process & Quality Management.
  • Acts as Process Owner for all GDMS processes and oversees Sub-Process Owners across the network.
  • Aligns training strategy with process requirements and role expectations.
  • Ensures process documentation and training meet regulatory requirements.
  • Assesses impact of process changes on documentation, training, and inspection readiness.
  • Collaborates with clinical programs to resolve quality/compliance escalations.
  • Serves as primary GDMS contact for audits/inspections and CAPA management.
  • Acts as Center of Excellence for process management and continuous improvement.
  • Develops metrics and risk indicators to drive performance improvements.
  • Engages stakeholders and leadership to ensure high-quality, compliant delivery.
  • Contributes to organizational strategy and transformation as a GDMS leader.
  • Strategy development and resource planning to meet organizational goals.

Skills

Adaptability
Audit Inspections
Clinical Data Management
Ethical Standards
GCDMP
GCP
Lean Continuous Improvement
People Leadership
Strategic Thinking
Team Leadership

Education

Bachelor's degree in life sciences or related field
ACRP certification or CCDM certification (preferred)
CMQ/OE or CQA / Lean Six Sigma (preferred)

Job description

Merck & Co. in the United States is seeking a Sr. Director and Head of GDMS Process & Quality Management to lead the development, implementation, and oversight of the GDMS framework and related training & quality activities.

This executive role reports to the Head of Global Data Management & Standards and sets the vision for GDMS, ensuring timely, high-quality delivery of services and regulatory compliance across the organization.

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