Director, External Lab Quality Oversight — Remote

Merck & Co.; United States; On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. is seeking a Director, Contract Testing Laboratories Quality Oversight to lead the quality oversight of external testing labs and cell banking QA globally.

You will set strategy, design, budget, and performance management for the CTL quality organization, ensuring GLP/GMP compliance and alignment with company policies and regulatory expectations. You will build and sustain a risk-based oversight model, drive operational leadership for testing activities, and collaborate across sites

Qualifications

• Minimum of ten (10) years of experience in Quality Systems, QA, and/or QC within pharmaceutical manufacturing operations 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 the strategy, organisational 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 our company's contract testing laboratories.
• Establishes and maintains a risk-based quality oversight model for cell banking.
• Provides operational leadership to the contract testing laboratories accountable for drug substance, drug product and finished product testing.
• Provides Quality oversight of the contract testing laboratories to ensure products are tested, stored and retained in accordance with regulatory expectations, GLP, GMP and our company's requirements.
• Provides Quality oversight to resolve quality issues, OOS investigations, and deviations that could impact launch or supply continuity across sites.
• Provides Quality oversight for analytical technology transfer.
• Defines clear performance expectations, metrics and governance routines to monitor and improve quality and operational performance.
• Lead Quality assessments for prospective contract test laboratories or new method citing and ensure gaps are remediated appropriately.
• Establish and maintain Quality agreements to protect our company's quality and compliance requirements.
• Direct, mentor, and develop a high-performing team of quality assurance professionals dedicated to external testing laboratory oversight.
• Promote a culture of accountability, collaboration, operational excellence, and proactive problem-solving across the internal organisation and external testing network.

Skills

Quality leadership

Change management

Coaching

Data integrity

Decision making

Good laboratory practices

Regulatory compliance

Manufacturing quality control

Operational leadership

Quality management systems

Education

Bachelor's degree in a scientific discipline

Job description

Merck & Co. is seeking a Director, Contract Testing Laboratories Quality Oversight to lead the quality oversight of external testing labs and cell banking QA globally.

You will set strategy, design, budget, and performance management for the CTL quality organization, ensuring GLP/GMP compliance and alignment with company policies and regulatory expectations. You will build and sustain a risk-based oversight model, drive operational leadership for testing activities, and collaborate across sites