Career Opportunities

Director, Quality Assurance

Description of Duties:

• The Director of Quality Assurance is responsible for the QA functions of the company, and provides supervision to QA managers and specialists.
• The Director provides leadership for the implementation, enhancement and application of quality programs at the company and is responsible for the quality of released products and all supporting product and operational documentation.
• The Director serves as the point of contact for communication with regulatory agencies relating to quality systems, as applicable.
• The Director plans internal and external quality audits in the areas of GMP, GLP and GCP and makes recommendations for continuous quality improvement and adherence to the appropriate quality standards.
• Ensures accuracy of data provided to regulatory agencies. Make quality systems inspection ready.

Job Qualifications:

• The candidate must possess a BS or MS degree.
• Ten years quality assurance/control experience
• Six years managerial/director level experience in FDA/EMEA regulated industry
• Must be thoroughly familiar with FDA and EMEA quality requirements for pharmaceutical products, biologics preferred
• Demonstrated leadership skills including influence, communication, project management, and employee management
• Knowledgeable in process, cleaning, viral inactivation and analytical method validation activities
• Auditing experience (external and internal)
• Experience with managing/implementing controlled document systems
• Experience with biologics, such as blood and plasma products, is desirable.
• Excellent analytical and strategic thinking skills
• Excellent communication skills (oral and writing)
• Experience in Phase III manufacturing of biologic.
• Experience with commercial manufacturing preferred.
• Experience with EU and FDA inspections.
• Travel: 5-10%