Global Director, CTL Quality Oversight

Merck; West Point (PA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Merck is seeking a Director of Contract Testing Laboratories Quality Oversight to lead the external quality organization responsible for CTLs and cell banking oversight globally. The role drives governance, risk management, and continuous improvement across GLP/GMP testing, ensuring patient safety and regulatory alignment.

The incumbent will build and mentor a high-performing QA team, implement performance metrics, and collaborate with internal and external partners to remediate gaps and

Qualifikationen

• Minimum 10 years of experience in Quality Systems, QA, and/or QC within pharmaceutical manufacturing under GMP and health authority requirements.
• Proven track record managing complex quality investigations, risk assessments and data-driven decisions.
• Strong regulatory compliance background with experience supporting regulatory inspections and health authority interactions.

Aufgaben

• Leads strategy, budget oversight and performance management of CTL quality oversight organization.
• Establishes risk-based quality oversight model for contract testing laboratories and cell banking.
• Provides operational leadership to labs for drug substance, drug product and finished product testing.
• Ensures GLP/GMP compliance and regulatory expectations are met across testing, storage and retention.
• Oversees investigations, OOS, deviations, and remediation to protect launch and supply continuity.
• Leads quality assessments for prospective labs and new methods; defines governance routines and metrics.

Kenntnisse

Change Management

Data Integrity

Quality Assurance

Regulatory Compliance

Leadership

Quality Auditing

Ausbildung

Bachelor's degree in a scientific discipline

Jobbeschreibung

Merck is seeking a Director of Contract Testing Laboratories Quality Oversight to lead the external quality organization responsible for CTLs and cell banking oversight globally. The role drives governance, risk management, and continuous improvement across GLP/GMP testing, ensuring patient safety and regulatory alignment.

The incumbent will build and mentor a high-performing QA team, implement performance metrics, and collaborate with internal and external partners to remediate gaps and