Senior Director, Biologics Quality & Vendor Oversight

Merck; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Long-term incentive program

Job summary

Merck is seeking a Senior Director for Biologics, DP, & Device Platform Lead within Global Development Quality. You will provide strategic and operational leadership across third-party quality management and due diligence for biologics, drug substances, sterile and non-sterile products, and medical devices.

The role leads a team of 9+ professionals, shapes quality strategy, and drives continuous improvement with vendors.

Qualifications

• Strong scientific and technical expertise across R&D and drug development.
• Deep knowledge of GMPs, regulatory expectations, and quality systems.
• Proven ability to drive cross-functional improvements in quality.

Responsibilities

• Lead TPQM & DD quality strategy and execution across vendor base.
• Oversee complex quality issues and regulatory interactions with senior leaders.
• Coach and develop a team of quality professionals.
• Collaborate with Global Auditing and other stakeholders on risk mitigation.

Skills

R&D expertise

Regulatory compliance (GMP)

Drug development knowledge

Continuous improvement

Quality risk management

Cross-functional leadership

Communication skills

People management

Education

Bachelor's degree in engineering, Biology, Chemistry, or related field

Job description

Merck is seeking a Senior Director for Biologics, DP, & Device Platform Lead within Global Development Quality. You will provide strategic and operational leadership across third-party quality management and due diligence for biologics, drug substances, sterile and non-sterile products, and medical devices.

The role leads a team of 9+ professionals, shapes quality strategy, and drives continuous improvement with vendors.