Director, Quality Assurance

Job Summary
The Director, Quality Assurance is responsible for ensuring that processes needed for Production Unit Quality Management Systems (QMS) requirements are documented, effectively established, and effectively maintained. This position will report to top management on the effectiveness of the quality system and any need for improvement, and this position will ensure the promotion and awareness of applicable regulatory requirements and quality system requirements throughout the organization.
Responsibilities

• Responsible for administration of Manufacturing Quality Assurance and Compliance to assure timely delivery of results to manage the company objectives and production as well as new product introduction on time. Review procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications. Oversee responsibility for the coordination/approval of Periodic Quality Reports (PQRs). Lead regulatory quality inspections of the facility.
• Interact regularly with Regulatory Affairs, Sales, Quality Assurance and Operations, Global Quality Management, and personnel. Routinely interact with Regulatory Agencies including, but not limited to, FDA and DEA.
• Quality decision authority to stop production and testing activities and contain materials and productions with immediate effect where critical deviations from regulatory requirements and/or Fresenius Kabi Quality Management System are noted.
• Directly manage the Quality department and performance of local quality systems including document control, training, CAPA, Supplier Controls Internal and External Audits, MQA/Batch Release, and Quality Control.
• Immediate notification to management on confirmed, reportable quality defects that become known from deviations, complaints, and other events and when notification to concerned Competent Authorities is required.
• Direct investigations of product complaints for manufactured products and completion of appropriate documentation. Provide technical details as required in a manner consistent with the confidential and proprietary nature of the information. Interact with the Medical Affairs and Vigilance Departments as needed.
• Participate in Regulatory/FDA inspections by providing information or expediting/obtaining information required by the inspectors. Schedule and conduct pre-inspection review of operations and follow-ups where corrective action is required. Facilitate external agency audits, inspections, and visits relative to the quality management system, including audit findings, responses, and corrective and preventative actions, as delegated.
• Collection and reporting of Quality KPIs.

Job Requirements:

• Bachelor's Degree in Engineering or related field
• 10+ years of previous Quality experience, with 5+ years in a leadership position
• Knowledge of appropriate FDA, ISO, and global regulations regarding quality systems
• Experience dealing directly with the FDA and notified bodies required

Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.