Director, External CTL Quality Oversight – Remote

Merck & Co.; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. in the USA is seeking a Director of Contract Testing Laboratories Quality Oversight to lead the external QA program for contracted testing and cell banking.

You will establish risk-based oversight, drive performance metrics, and ensure GLP/GMP compliance across global CTLs and storage with a focus on patient safety. The role requires a strong QA leadership background, experience with regulatory inspections, and the ability to travel about 30% to support multiple sites.

Qualifications

• Bachelor's degree in a scientific field required.
• 10+ years in Quality Systems, QA, or QC within pharmaceutical manufacturing under GMP and health authority requirements.
• Proven track record managing complex quality investigations and risk assessments.
• Strong compliance background with regulatory inspections and health authority interactions.
• Demonstrated success leading and developing teams.

Responsibilities

• Leads strategy, budget oversight and performance management of the CTLs 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 the contract testing laboratories for drug substance, drug product and finished product testing.
• Provides quality oversight of testing, storage and retention in line with regulatory expectations and GLP/GMP.
• Supports resolution of quality issues and OOS investigations that could impact launch or supply continuity.
• Oversees analytical technology transfer quality.
• Defines performance metrics and governance routines to monitor and improve quality and operational performance.
• Leads quality assessments for prospective contract test laboratories and new method citations, remediating gaps.
• Establishes and maintains quality agreements to protect company quality and compliance.
• Directs, mentors and develops a high-performing quality assurance team dedicated to external testing oversight.
• Promotes accountability, collaboration, operational excellence, and proactive problem-solving across the organization and external network.

Skills

Quality Assurance

GxP Compliance

Regulatory Inspections

Team Leadership

Risk Management

Travel readiness

External partner oversight

Education

Bachelor's degree in scientific discipline

Job description

Merck & Co. in the USA is seeking a Director of Contract Testing Laboratories Quality Oversight to lead the external QA program for contracted testing and cell banking.

You will establish risk-based oversight, drive performance metrics, and ensure GLP/GMP compliance across global CTLs and storage with a focus on patient safety. The role requires a strong QA leadership background, experience with regulatory inspections, and the ability to travel about 30% to support multiple sites.