QA Strategy Lead – Facilities & Validation

Merck; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Job summary

Merck in Rahway, NJ is seeking an Associate Director of Quality Assurance to lead quality operations for facilities, validation, and low bioburden environments supporting clinical development. You will oversee GMP QA activities, drive design-to-start-up quality, and maintain compliance across projects while partnering with cross-functional teams.

The role requires building strong relationships, delivering pragmatic solutions in a fast-paced environment, and guiding capital projects through

Qualifications

• Bachelor’s degree in science, engineering, or related field.
• Minimum of 8 years’ experience in Pharmaceutical/Biotechnology with cGMP knowledge and related functions.

Responsibilities

• Manage Quality oversight of GMP facilities and related assets.
• Lead QA activities for qualification and validation of facilities, equipment, and automation.
• Provide Quality oversight of GMP processes including calibration, change management, risk management, batch review, and investigations.
• Support capital asset lifecycle from design through start-up to compliant manufacture and testing of clinical material.
• Build collaborative relationships and communicate across organizations.
• Identify efficiency opportunities and implement value-added solutions.
• Demonstrate a Quality mindset balancing operations with compliant solutions.
• Ensure industry best practices are applied to new GMP facilities and equipment.

Skills

Compliance Investigations

Conflict Management

Cross-Functional Project Management

Deviation Management

GMP

Operational Quality

Project Leadership

Project Life Cycle Management

Project Risk Assessments

Quality Assurance Systems

Quality Auditing

Quality Management

Quality Oversight

Quality Risk Management

Quality Systems Compliance

Regulatory Compliance

Strategic Thinking

Education

Bachelor’s degree in science/engineering or related field

Job description

Merck in Rahway, NJ is seeking an Associate Director of Quality Assurance to lead quality operations for facilities, validation, and low bioburden environments supporting clinical development. You will oversee GMP QA activities, drive design-to-start-up quality, and maintain compliance across projects while partnering with cross-functional teams.

The role requires building strong relationships, delivering pragmatic solutions in a fast-paced environment, and guiding capital projects through