director of quality assurance

Location: Wilmington, OH

Direct Hire

Are you a Director of Quality Assurance that would love the opportunity to work for one of the top three largest global healthcare companies?  Don't miss your chance and apply today! 

What you will be doing as the Director of Quality Assurance:

  • Primary decision maker on matters impacting the quality assurance function. Responsible for establishing policies and standards.
  • Ensure that department is staffed appropriately and the required initial and continuing education of personnel is carried out and adapted according to need.
  • Responsible for oversight of batch review, line clearance, general manufacturing services, qualification review, product release and clinical release.
  • Management oversight of Quality systems – deviations, product and process investigations, product complaints, change control, internal audits compliance risk, audit readiness, data integrity and supporting management tools.

What you will need as the Director of Quality Assurance :

  • 15 year experience in the Pharmaceutical Industry with progressive Quality leadership competency.
  • Significant managerial role in Quality (at least 5 years).
  • Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
  • Good communication skills at all levels of the organization.
  • A leader of people who uses influence, coaching skills and persuasion to accomplish objectives in a cross-functional team environment.
  • Experience of an FDA regulated site.
  • A thorough working knowledge of regulatory compliance, process validation, technology transfer, plant engineering and competent PC skills.
  • Able to grasp complex technical issues and make sound decisions based on data and information from various sources.
  • Expert knowledge of Quality Operations in a pharmaceutical manufacturing environment
  • Parenteral experience is essential.
  • Experience in developing and implementing a CGMP compliance program in association with bringing a product through clinical trials to commercialization.
  • This position is expected to be flexible in work hours to meet the business needs and may travel 15% of the time.