Director, Global Product Quality - Manufacturing

Responsibilities

• Oversee quality and compliance of GMP suppliers for contract manufacturing and testing services
• Establish and manage Quality Systems for batch record review and product disposition
• Maintain Quality Management Systems for GMP activities related to clinical and commercial products
• Lead investigations into product quality issues and oversee CAPA implementation
• Develop and maintain SOPs and associated documentation for quality systems
• Ensure compliance of Quality Agreements with suppliers
• Represent global product quality during technical transfer activities

Qualifications

• Bachelor's degree in Biology, Chemistry, or related field
• Minimum 12 years of experience in QA or pharmaceutical manufacturing, focusing on GMP activities
• In-depth knowledge of drug development processes and cGMP regulations
• Strong capability to manage relationships with internal clients and GMP suppliers
• Experience in Small Molecule API and Drug Product manufacturing
• Proficient in analytical problem solving and risk management
• Willingness to travel domestically (30%) and occasionally internationally

Compensation

$169,222 – $253,000 annually