Remote Director, Global CTL Quality Oversight

Msd Ireland; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. seeks a Director of Contract Testing Laboratories Quality Oversight to lead the external QA oversight for contracted testing globally.

This role ensures GLP and GMP compliance across drug substance, drug product, and finished product testing, driving continuous improvement and issue resolution. The incumbent will shape quality governance, mentor a high-performing team, and collaborate with external partners to maintain product integrity and supply continuity.

Qualifications

• Ten years of experience in Quality Systems, QA, and/or QC within pharmaceutical manufacturing under global GMP requirements.
• Proven track record managing complex quality investigations, assessing risk, and making data-driven decisions.
• Strong compliance background with experience supporting regulatory inspections and health authority interactions.
• Demonstrated success leading and developing teams.
• Travel approximately 30% of the time.

Responsibilities

• Leads strategy and governance for contract testing laboratories and cell bank quality oversight.
• Establishes risk-based quality oversight model for CTLs and for cell banking.
• Provides operational leadership to laboratories for drug substance, drug product and finished product testing.
• Oversees testing, storage and retention per GLP, GMP and company requirements.
• Resolves quality issues, OOS investigations, and deviations affecting launches or supply continuity.

Skills

Quality Systems

Quality Assurance

Regulatory Compliance

Leadership

Risk Management

Data-Driven Decisions

Quality Auditing

Team Development

Education

Bachelor’s degree in a scientific discipline

Job description

Merck & Co., Inc. seeks a Director of Contract Testing Laboratories Quality Oversight to lead the external QA oversight for contracted testing globally.

This role ensures GLP and GMP compliance across drug substance, drug product, and finished product testing, driving continuous improvement and issue resolution. The incumbent will shape quality governance, mentor a high-performing team, and collaborate with external partners to maintain product integrity and supply continuity.