GMP Data & Digital Quality Leader

MSD

West Point (PA)

Presencial

USD 173.000 - 273.000

Jornada completa

Hace 3 días
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Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision
401(k) Retirement Plan
Paid holidays and vacation

Descripción de la vacante

MSD is seeking a DDQ Director to lead the Digital and Data Quality organization and oversee quality controls for GMP computerized systems across the Company Manufacturing Division. Responsibilities include IT applications, automated manufacturing and packaging equipment, automated lab systems, data tools, and emerging technologies.

You will collaborate with Quality Operations, IT, External Manufacturing, and Manufacturing to ensure compliance and data integrity; oversee audits, staffing,

Formación

  • Bachelor's degree in Science, IT, Engineering, or related field required.
  • Master's or Ph.D. with 7+ years in regulated pharmaceutical manufacturing preferred.
  • Experience delivering validated enterprise systems in regulated environments.

Responsabilidades

  • Support regulatory inspections and audits.
  • Effectively manage DDQ resources.
  • Participate in hiring, training, and development of DDQ staff.
  • Coach and develop direct reports.
  • Align team goals with regulatory expectations and quality objectives.

Conocimientos

Change Management
Coaching
Data Integrity
Decision Making
Interpersonal Relationships
Manufacturing Quality Control
Operational Efficiency
People Leadership
Quality Auditing
Quality Management Standards
Quality Risk Management
Regulatory Compliance
Results-Oriented
Risk Management
Strategic Thinking
Lean Six Sigma
PMP

Educación

Bachelor's degree
Master's degree
Ph.D.

Herramientas

GAMP

Descripción del empleo

MSD is seeking a DDQ Director to lead the Digital and Data Quality organization and oversee quality controls for GMP computerized systems across the Company Manufacturing Division. Responsibilities include IT applications, automated manufacturing and packaging equipment, automated lab systems, data tools, and emerging technologies.

You will collaborate with Quality Operations, IT, External Manufacturing, and Manufacturing to ensure compliance and data integrity; oversee audits, staffing,

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