Associate Director Quality

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

Job Description

Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment with our incredibly high standards of quality while meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment with our incredibly high standards of quality while meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

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

The individual is an advocate and leader for