Senior Director, Site Quality & Compliance

MSD Malaysia; West Point (PA); On-site; USD 129,000 - 203,000; Full time

Job summary

Merck & Co., Inc., Rahway, NJ, USA, seeks an Associate Director within Quality to provide direction and oversight at a site, covering CGMP, training, documentation, annual product review, change control, inspection management, and risk management. Leads a team of Quality Specialists to ensure products are manufactured and tested per approved processes.

The role requires BS or MS in science/engineering with extensive regulatory experience (FDA/EMEA) and strong leadership and continuous

Qualifications

• Bachelor’s degree in science, engineering, or another technical field with eight (8) years’ experience in a functional area such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or SupplyChain.
• Master’s degree in Science, Engineering, or another technical field with six (6) years’ experience in a functional area such as Operations, Quality, TechnicalOperations, Technology, Engineering, Maintenance, and/or SupplyChain.

Responsibilities

• Provide quality direction and oversight to one site to ensure CGMP compliance, training, documentation, and quality system processes.
• Lead and develop Quality Specialists and partner with operations to ensure products are manufactured and tested per approved processes.
• Drive quality improvement initiatives and align quality priorities across the organization.
• Ensure compliance with regulatory and internal requirements through risk management and effective inspection management.

Skills

CGMP knowledge

FDA regulations

EMEA regulations

GMP experience

Quality assurance

Leadership

Auditing

Risk management

Education

Bachelor's degree in science/engineering

Master’s degree in science/engineering

Job description

Merck & Co., Inc., Rahway, NJ, USA, seeks an Associate Director within Quality to provide direction and oversight at a site, covering CGMP, training, documentation, annual product review, change control, inspection management, and risk management. Leads a team of Quality Specialists to ensure products are manufactured and tested per approved processes.

The role requires BS or MS in science/engineering with extensive regulatory experience (FDA/EMEA) and strong leadership and continuous