Senior Director, Quality Assurance

Merck seeks a Senior Director to lead third-party quality management and due diligence for biologics, drug products, and medical devices across the global development supply chain. This strategic role oversees a team of nine quality professionals, ensuring vendor compliance and driving continuous improvement initiatives.

Responsibilities

• Oversee team of approximately nine quality professionals managing designated vendor base
• Execute daily operational third-party quality management support for biologics and drug product outsourcing activities
• Develop and drive execution of quality strategies and improvement initiatives aligned with business objectives
• Resolve complex contractor and vendor quality, compliance, and business practice issues across functions
• Support auditing activities, mitigation of audit observations, and cross-functional stakeholder engagement on regulatory matters

Requirements

• Bachelor's degree in engineering, biology, chemistry, or related field
• Minimum 10+ years pharmaceutical industry experience or advanced degree with 8+ years relevant experience
• Deep knowledge of clinical development processes and regulatory requirements in R&D environment
• Demonstrated expertise in quality risk management and continuous improvement methodologies
• Proven experience leading complex cross-functional initiatives and managing high-performing teams
• Experience interacting with regulatory officials and external auditing parties