Director, Digital Quality & Data Integrity

Regulatory Jobs; West Point (PA); Híbrido; USD 173.000 - 273.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision

401(k) retirement plan

Paid holidays and vacation

Descripción de la vacante

Merck & Co., Inc. is seeking a DDQ Director in the USA, Pennsylvania, West Point, to lead GMP computerized systems quality across Manufacturing.

The role oversees IT applications, automated equipment, and data analysis tools, ensuring data integrity and regulatory compliance throughout the lifecycle. The position calls for expert knowledge of FDA/ICH guidelines, GMP data controls, and quality management systems, with responsibilities spanning audits, staff leadership, and cross-functional

Formación

• Bachelor's degree in Science, IT, Engineering, or related field.
• Master's degree with 12+ years of experience in regulated pharmaceutical manufacturing and validated enterprise systems.
• Ph.D. with 7+ years of experience in regulated pharmaceutical manufacturing and validated enterprise systems.

Responsabilidades

• Support regulatory inspections and audits.
• Effectively and efficiently manage DDQ resources.
• Participate in the hiring, training, development, and management of DDQ employees.
• Coach and develop direct reports.
• Proactively align team and individual goals with regulatory expectations and our quality objectives.
• Model and reinforce leadership behaviors, values, and culture.

Conocimientos

Regulatory compliance

Computerized validation

Quality systems

Leadership

Data integrity

Regulatory inspections

Educación

Bachelor's degree in Science/IT/Engineering

Master's degree in Science/IT/Engineering/Business

Ph.D. in related discipline

Descripción del empleo

Merck & Co., Inc. is seeking a DDQ Director in the USA, Pennsylvania, West Point, to lead GMP computerized systems quality across Manufacturing.

The role oversees IT applications, automated equipment, and data analysis tools, ensuring data integrity and regulatory compliance throughout the lifecycle. The position calls for expert knowledge of FDA/ICH guidelines, GMP data controls, and quality management systems, with responsibilities spanning audits, staff leadership, and cross-functional