FierceBiotech and FiercePharma Jobs
Manager - QA Systems - Covance
Nov 10
Location: Greenfield, INCategories: All Categories
Website: http://www.covancecareers.com
Position Description
Covance is expanding its biotechnology services business to the United States. This is an exciting opportunity to get in on the ground floor of a rapidly growing scientific service offering with one of the world’s premier drug development companies. The biotechnology business unit will provide a comprehensive portfolio of contract GLP and GMP laboratory services supporting the development and manufacture of biotechnology, biopharmaceutical and vaccine products.
We are currently seeking a Manager of QA Systems for our biotechnology lab in Greenfield IN. As the manager you will:
• Establish Quality systems to support study and client needs
• Manage Quality review and compliance , participate in regulatory inspections, oversee GMP documentation, and electronic Quality Management systems of the Biopharmaceutical lab.
• Provide management direction to the Quality Systems team.
Qualifications include:
• BS degree and 5-10 years in Quality Systems.
• Experience with GMP compliance in the biotechnology, biopharmaceutical or related contract testing industry required.
• GLP experience a plus.
• Experience with compliance review, regulatory inspections, GMP documentation, and electronic Quality Management systems desired.
• LIMS, VelQuest or Documentum experience preferred.
• Sample receipt/management experience a bonus.
• Prior experience managing people is needed.
• Experience with regulatory inspections and startup operations are desirable.
At Covance, you can make a difference, not only by helping to deliver life-saving and life-enhancing medicines to people around the world, but also by helping us become a great company. We are committed to delighting our clients with the broadest and best service portfolio in our industry. This ever-changing environment energizes our people and offers exceptional growth opportunities.
