Associate Director, Quality Assurance

Overview

The Associate Director, Quality Assurance will provide cross functional quality assurance support to manufacturing, quality control, clinical and non-clinical operations. This role will be responsible for QA business processes supporting GMP, GCP and GLP compliance, regulatory inspection readiness, quality planning and continuous improvement projects and will provide leadership and direction to the QA team and operational colleagues on quality matters. The Associate Director, Quality Assurance will act as an internal consultant to operational counterparts providing QA support and guidance for clinical, non-clinical, manufacturing, and pharmaceutical development operations representing QA on project teams and discussions. This role will be directly involved with quality processes including, but not limited to, change control, deviations and investigations, internal audit, supplier qualification and audit, batch review and annual product review.

Responsibilities

• Review and/or approve specific quality documents consistent with procedural requirements; including, but not limited to, deviations, investigations, change controls, procedures, annual product reviews, validation documentation, Quality Agreements, clinical study documents.

• Responsible for the escalation of critical quality issues as appropriate to Quality Management

• Provide technical leadership and advice for key Quality issues and initiatives.

• Identify, prioritize, and support the implementation of continuous improvement initiatives, to maintain compliance while striving to meet business and customer needs.

• Maintain a continued state of GXP compliance and readiness for partner audits, Pre-Approval Inspections (PAIs), Bioresearch Monitoring Program (BIMO) and Routine GMP Inspections by regulatory agencies at Xeris facilities and contract facilities.

• Manage Pre-approval Inspection Readiness at Xeris and at contract organizations.

• Work with the Regulatory Affairs and Quality department to support Heath Authority Inspections.

• Promote continued alignment in quality business processes across the organization.

• Develop, improve and implement the systems and processed needed to operate at the required level of quality and efficiency leveraging existing company knowledge and practices where necessary, but also incorporating external experiences and learning.

• Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach.

• Support project teams as they deliver products, projects and programs, by providing upfront input, feedback and support on decisions & strategies. Collaborate with project teams to ensure the right decisions are made to meet project deliverables, strategic goals and quality and compliance expectations.

• Contribute to the Global SQM processes with an immediate focus on global suppliers including supporting supplier identification and selection; supplier evaluation and approval; supplier quality agreements; supplier performance monitoring and supplier relationship management.

• Coordinate and participate in/lead supplier/ vendor and clinical investigator site audits.

• Provide reporting of requested quality metrics to the Quality Management Review Chair.

• Participate in review of manufacturing and testing of new products to ensure quality compliance, and that all products meet or exceed customer requirements.

• Provide clinical quality oversite to studies and provide quality insights and support as needed.

• Other duties as assigned by the Sr. Director of Quality.

Qualifications

• A minimum of a bachelor's degree required in Engineering, Sciences or other related fields.

• Minimum of 8+ years in quality, compliance, and pharmaceutical quality management, including GXP facility audits, in a regulatory environment (FDA, MHRA, Notified Body, etc) required.

• Experience with regulatory inspections.

• Excellent working knowledge of GMP/GCP/GLP regulations and sources of regulatory information (FDA, EU GMP, ICH, PIC/s etc.)

• Competencies: Analytical Skills, Strong decision-making Skills, Adaptability, Teamwork & Collaboration, Organizational skills, Problem Solving, Written and Verbal Communications, Attention to Detail

Working Conditions

• This position is a hybrid role located in Xeris' Chicago office. A minimum of three days per week in the office is required. On site requirements may change at management's discretion.

• Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.

• Some of the work performed is in a typical office environment and includes long periods of sitting at a desk as well as 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 25 pounds of force occasionally.

• Travel up to 25 - 40%.

NOTE: This job description is not intended to be all-inclusive. Employee 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.