Director, Digital & Data Quality (GMP)

Merck; West Point (PA); Presencial; USD 173.000 - 273.000; Jornada completa

Descripción de la vacante

Merck in USA, Pennsylvania, West Point seeks a DDQ Director to lead the DDQ organization and ensure GMP computerized systems compliance across Quality, IT, and Manufacturing functions. You will oversee validation, data integrity, and risk management throughout the lifecycle of computerised systems.

The role requires extensive regulatory knowledge, leadership of cross-functional teams, and a proven track record in regulated pharmaceutical manufacturing.

Formación

• Expert knowledge of applicable regulations and guidance (FDA, EU, ICH, 21 CFR 11 and related parts).
• Hands-on experience validating computerized systems and ensuring compliance.
• Experience implementing quality systems in regulated pharma/manufacturing 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 QA objectives.
• Model leadership behaviors and company values.

Conocimientos

Leadership

Regulatory compliance

Quality systems

Data integrity

Educación

Bachelor's degree

Master's degree

Ph.D.

Descripción del empleo

Merck in USA, Pennsylvania, West Point seeks a DDQ Director to lead the DDQ organization and ensure GMP computerized systems compliance across Quality, IT, and Manufacturing functions. You will oversee validation, data integrity, and risk management throughout the lifecycle of computerised systems.

The role requires extensive regulatory knowledge, leadership of cross-functional teams, and a proven track record in regulated pharmaceutical manufacturing.