Director, Contract Testing Laboratories Quality Oversight

Director leading global quality oversight strategy for Merck's contract testing laboratories and cell banking operations. Accountable for regulatory compliance, risk-based quality models, team leadership, and ensuring products meet GMP, GLP, and company standards across multiple international sites.

Responsibilities

• Lead strategy, organizational design, budget oversight, and performance management of contract testing laboratory quality organization
• Establish and maintain risk-based quality oversight models for contract testing labs and cell banking operations
• Provide quality oversight for drug substance, drug product, and finished product testing to ensure regulatory and GMP compliance
• Direct quality investigations, OOS resolutions, and deviation management to protect launch and supply continuity
• Direct, mentor, and develop high-performing quality assurance team while promoting accountability and operational excellence

Requirements

• Bachelor's degree in scientific discipline
• Minimum 10 years quality systems, assurance, or control in pharmaceutical manufacturing under GMP
• Proven experience managing complex quality investigations and risk assessment
• Strong compliance background with regulatory inspection and health authority experience
• Demonstrated leadership and team development capability
• Ability to travel approximately 30% of the time