Director, CTL Quality Oversight (Remote)

Merck; New York (NY); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck in the United States seeks a Director, Contract Testing Laboratories Quality Oversight to lead QA for contracted testing, ensure GLP/GMP compliance, and drive risk-based oversight across labs and cell banking.

This role leads a global, high-performing team and partners with external networks to shape quality governance, investigations, and remediation that safeguard product launches and supply continuity.

Qualifications

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

Responsibilities

• Leads strategy, design, budget oversight and performance management of the contract testing laboratories and cell bank quality oversight organisation.
• Establishes and maintains a risk-based quality oversight model for contract testing laboratories.
• Establishes and maintains a risk-based quality oversight model for cell banking.
• Provides operational leadership to labs for drug substance, drug product and finished product testing.
• Oversees quality oversight to ensure testing, storage and retention per GLP/GMP and company requirements.
• Resolves quality issues, OOS investigations, and deviations impacting launch or supply.
• Oversees analytical technology transfer.
• Defines performance metrics and governance routines to monitor and improve quality and operational performance.
• Leads quality assessments for prospective contract test laboratories or new method citing and ensure gaps are remediated.
• Establishes and maintains quality agreements with partners to protect quality and compliance.
• Directs and develops a high-performing team of QA professionals dedicated to external testing laboratory oversight.
• Promotes accountability, collaboration, operational excellence, and proactive problem-solving across the organization and external network.

Skills

Quality systems

Quality assurance

Quality control

Leadership

Risk assessment

Education

Bachelor's degree in a scientific discipline

Job description

Merck in the United States seeks a Director, Contract Testing Laboratories Quality Oversight to lead QA for contracted testing, ensure GLP/GMP compliance, and drive risk-based oversight across labs and cell banking.

This role leads a global, high-performing team and partners with external networks to shape quality governance, investigations, and remediation that safeguard product launches and supply continuity.