Senior Director, Biologics Quality & TPQM

Merck; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck in Rahway, NJ seeks a Senior Director for Biologics, DP, & Device Platform Lead within Global Development Quality. You will oversee TPQM & DD, manage a team of 9+ professionals, and drive strategic third-party quality and due diligence for biologics and medical devices across development programs.

You will define quality strategies, partner with global auditing, and lead cross-functional initiatives to elevate compliance and process improvements.

Qualifications

• Bachelor's degree in engineering, biology, chemistry, or related field.
• 10+ years of relevant pharmaceutical/biotech experience.
• Experience with regulatory officials and external audits.

Responsibilities

• Lead strategic operational TPQM & DD initiatives for vendor base.
• Oversee third-party quality processes and mitigate risk in development programs.
• Coach and develop a team of Quality professionals.
• Collaborate with senior leadership on quality/regulatory matters.

Skills

Leadership

Quality Management

Regulatory Knowledge

Cross-functional Collaboration

Strategic Planning

Process Improvement

People Leadership

Auditing & Compliance

Education

Bachelor's degree in Engineering

Biology

Chemistry

Related field

Job description

Merck in Rahway, NJ seeks a Senior Director for Biologics, DP, & Device Platform Lead within Global Development Quality. You will oversee TPQM & DD, manage a team of 9+ professionals, and drive strategic third-party quality and due diligence for biologics and medical devices across development programs.

You will define quality strategies, partner with global auditing, and lead cross-functional initiatives to elevate compliance and process improvements.