Associate Manager, Quality Assurance & Complaints - Xeris Pharmaceuticals, Inc.

The Associate Manager, Quality Assurance and Complaints will be responsible for supporting the Quality Assurance department through Quality Management System activities. This position plays a key role to ensure that customer complaints and deviation investigations are documented and addressed promptly and in accordance with regulatory requirements. This position will also assist with the continuous improvement of the Quality Management System at Xeris.

• Responsible for customer complaints including performing investigations, root-cause analysis, implementation of CAPA, and being the point of communication with customers.
• Review and continuously lead efforts to improve the complaint-handling process.
• Partners with Manufacturing, Technical Operations, and Product Development teams to conduct information-gathering sessions and lead GMP deviation investigations.
• Responsible for identifying any trends in product complaints that are found during the complaint handling process, and alerting management in a timely manner.
• Ensure that all documentation is completed promptly and follows established policies, practices, and procedures.
• Maintain metrics and data to report the performance of the complaint investigation process. Provides regular updates and status reports to senior management.
• Participate in the review of manufacturing and testing of new products to ensure quality compliance and that all products meet or exceed customer requirements.
• Author/Revise SOPs and policies as needed.
• Provide quality support and representation for cross-functional initiatives and projects.
• Ensures regulatory compliance in quality system processes with FDA Quality System Regulation and ISO 13485 regulatory requirements.
• Assists with other Quality-owned processes, including, but not limited to, Corrective and Preventive Actions (CAPAs), Nonconformance Reporting (NCR), change control activities, and organizing data for Management Reviews.
• Maintains confidentiality and sensitivity.
• Conducts routine quality audits and root cause analysis to understand factors contributing to potential policy or procedure violations.

• Bachelor’s Degree preferred
• 3-5 years prior work experience in medical devices, pharmaceuticals, biologics, or other regulated industries.
• Experience with investigations, root cause analysis, and CAPA implementation.
• Ability to autonomously lead investigations from start to finish
• Demonstrated knowledge of FDA Quality System Regulations and ISO 13485 or ISO 9001 (e.g., Customer Related Processes, CAPAs, Risk Management, Failure Investigation, etc.). 
• Experience with Quality Assurance and Regulatory compliance, principles, and systems.
• Experience in the use of a change control system.
• Microsoft Office proficiency (Word, Excel, PowerPoint)
• Competencies: Adaptability, Project Management, Problem Solving, Critical Thinking, Self-Starter, Quality-driven, Written & Verbal Communication skills, Organizational skills, Teamwork & Collaboration, Interpersonal skills

Working Conditions

• Position may require periodic evening and weekend work, as necessary to fulfill Periodic overnight travel – approximately 10% anticipated.
• This role is based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at management’s discretion.
• Some of the work performed is in a typical office environment and includes long periods of sitting at a desk, and frequent usage of hands and computer.
• This position does require moderate amounts of walking, standing, bending, kneeling, stooping, pushing, pulling, reaching, lifting, and twisting.
• Employee may be required to exert up to 50 pounds of force occasionally, and/or up to 20 pounds frequently, and/or up to 10 pounds of force constantly to move objects.

NOTE: This job description is not intended to be all-inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.