Manager, Quality Assurance

Division Overview: Job Overview : Responsibilities:

• Vendor Management Responsibilities (Primary):
  • Own the vendor management process
  • Manage audit schedules, perform GxP audits (domestic and international), write audit reports and manage responses
  • Manage the Vendor List and Approved Vendor List
  • Perform audit report reviews and approve audit reports by 3rd party auditors
  • Support client audits and regulatory inspections as host or direct support
• Quality Assurance Responsibilities (Secondary):
  • Review of batch records/product disposition, as needed
  • Review of deviations/OOS/ complaint investigations/ change controls, as needed
  • Review or author/update SOPs
  • Assist with the review of other supporting documentation
  • Author/assist with Quality Agreements
  • Internal Audits
  • Assist with Regulatory Agency inspections/Marketing Partner audits

Qualifications - Skills & Requirements:

• Highly organized with great attention to detail
• Strong computer skills, including MS Office (Word, Excel, PowerPoint); SharePoint
• Strong knowledge of global regulations for commercial & clinical operations

Education & Experience:

• 7 years experience in Pharmaceutical Quality Assurance required
• 5 years experience performing GMP audits required
• Experience with GMP & GCP audits preferred
• Bachelor’s Degree from accredited university
• ASQ Quality Auditor Certification preferred

Physical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). •Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements: No Additional Requirements Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.