Director of Quality Assurance (Durham)

Must Haves :

• Bachelor's Degree with 12+ years of experience OR Master's Degree with 10+ years of experience in a QA or GMP environment
• Experience in a QA role supporting validation, engineering, IT and change control
• Experience managing a QA organization in for both clinical and commercial operations
• Previous experience in validation or engineering
• Proven ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

Job Description :

This individual will lead and direct all QA activities supporting Facility Engineering, Validation and IT in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, and facilities. Provide quality oversight of facility upgrades and expansions. This individual is responsible for managing the change control system. Cultivate and maintain Quality Assurance staff by recruiting, training, and managing QA team members. Align QA organization to meet companies strategic goals.

Responsibilities :