Associate Director, Drug Substance Quality Excellence

Merck; West Point (PA); On-site; USD 140,000 - 230,000; Full time

Job summary

Merck's Quality organization ensures materials and processes across our manufacturing network meet the highest standards of quality and regulatory compliance, from development through distribution.

The Associate Director within Quality is responsible for providing quality direction and oversight to a Drug Substance capital project, including Training, Documentation, Change Control, Inspection Management, QMS, and Risk Management to maintain regulatory compliance.

Qualifications

• Lead quality direction and oversight for a Drug Substance capital project.
• Ensure compliance with regulatory requirements and Quality Management System.
• Advocate and leadership responsibilities within the Quality organization.

Responsibilities

• Provide quality direction and oversight to the Drug Substance capital project.
• Maintain compliance with regulatory requirements and Quality Management System, including Training, Documentation, Change Control, Inspection Management, and Risk Management.

Job description

Merck's Quality organization ensures materials and processes across our manufacturing network meet the highest standards of quality and regulatory compliance, from development through distribution.

The Associate Director within Quality is responsible for providing quality direction and oversight to a Drug Substance capital project, including Training, Documentation, Change Control, Inspection Management, QMS, and Risk Management to maintain regulatory compliance.