Aurora , IL , United States
Install develop or maintain quality systems that ensure that all operations comply with applicable regulatory standards.
Direct lead develop and manage functional personnel and structure. Interact effectively with cross-functional personnel to sustain and improve total operational excellence. Provide direction and leadership as a member of the site management team.
Qualifications: 10+ years demonstrated QA experience obtained from the Pharmaceutical / Medical Device industry. 8+ years of managerial experience within the industry. Sound knowledge of FDA cGMP requirements (exposure to global regulations a plus). Excellent writing/communication and computer skills are required. Good interpersonal leadership and managerial skills. Expertise in Technical writing nonconformance investigation and conflict resolution. Demonstrated competency in managing QA departments. Demonstrated knowledge of Management of Quality Operations and processes. Demonstrated ability to communicate clearly and professionally both in writing and verbally.
Ability to create and maintain effective industry networking relationships to influence and provide direction for cGMPs etc. Specialized Training: Computer experience with Microsoft Office and database-type software is a must
• EDUCATION: Bachelor’s degree in Chemistry or Microbiology or related scientific discipline. Master’s degree in Chemistry / Microbiology preferred.