Director, Quality Assurance

Job SummarySalary Range: $165,000 to $200,000
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, abilities and working shift.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision.
The Director, Quality Assurance is responsible for ensuring that processes needed for Production Unit 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. This position services as the management representative for the site.

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.  Reviews procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications. Oversees responsibility for the coordination/approval of Periodic Quality Reports (PQRs).  Leads regulatory quality inspections of the facility. Assumes responsibility for major projects assigned by Manager.
• Works independently of direct supervision but interacts with all levels within the site organization on a daily basis. Interacts regularly with Regulatory Affairs, Sales, Quality Assurance and Operations, Global Quality Management, and personnel. Routinely interacts 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 manages 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.
• Immediate notification to management on data integrity issues that become known.
• Regularly assess the quality management system, via internal audits and other applicable monitoring methods.
• Report to top management regarding the compliance and effectiveness of the quality management system.
• Directs investigations of product complaints for manufactured products and completion of appropriate documentation. Provides technical details as required in a manner consistent with the confidential and proprietary nature of the information. Interacts with the Medical Affairs and Vigilance Departments as needed.
• Participates in Regulatory/FDA inspections by providing information or expediting/obtaining information required by the inspectors. Schedules and conducts 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.
• Ensure the promotion of awareness of customer requirements and regulatory requirements throughout the organization.
• Collection and reporting of Quality KPIs.
• Assurance that all products are released at the site, compliant with the quality management system, registration and GMP requirements.
• Support investigation of incoming complaints.
• Fosters an open environment of continuous improvement that drives quality employee engagement and meets pragmatic business needs.  
• Coaches and provides critical quality thinking, mentoring, and appropriate escalation.
• Influences effective compliance-based decisions with cross functional communication and team building skills.
• Interacts with other Quality Units within the division and larger company.
• Ensures adequate training is provided and complete for employees in their respective function.
• Responsible for ensuring the Quality Management System requirements are met under ISO 9001 standards

REQUIREMENTS

• Bachelor’s degree in Engineering or a related field, 
• 10 years of previous Quality experience with 5 years in a leadership position
• Computer technical hardware/Software knowledge is a plus
• Knowledge of appropriate FDA, ISO, and global regulations regarding quality systems.  
• The ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
• Experience dealing directly with FDA and notified bodies required.
• Strong, practical, and pragmatic knowledge of both US and global Quality system requirements and medical device/ biologics production.
• Must have the ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve goals.

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 contribution, 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.