Clinical Quality Assurance (CQA) Manager

Overview The Clinical Quality Assurance (CQA) Manager plays a key role in ensuring that all clinical trial activities are conducted in compliance with global regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal quality standards. This position supports the development, execution, and continuous improvement of the companyu2019s clinical quality system, helping to safeguard patient safety, data integrity, and regulatory readiness across all clinical programs. In addition to core GCP responsibilities, this role provides quality oversight of clinical labeling processes, human factors activities and where required non-clinical activities. This role is critical in ensuring compliance with global regulatory standards, maintaining relevant related quality standards, and fostering strong partnerships with internal and external clinical development teams, device development, labeling and non-clinical partners. Responsibilities u2022 Assist in the development, review, and maintenance of quality documents, including SOPs, work instructions, quality agreements, and quality plans. u2022 Support the planning, execution, and followu2011up of GCP& GLP audits, including investigator sites, CROs, laboratories, and internal process audits. u2022 Monitor clinical trial activities to ensure compliance with ICHu2011GCP, GMP and GLP applicable regulations, and company SOPs. u2022 Partner with Clinical Development, Regulatory Affairs, Pharmacovigilance, device development, labeling, non-clinical and other crossu2011functional teams to provide GxP guidance and quality support. u2022 Participate in vendor qualification and ongoing vendor oversight activities as requested. u2022 Track and manage deviations, CAPAs, audit findings, and quality issues to ensure timely and effective resolution. u2022 Support inspection readiness activities and participate in regulatory inspections as needed. u2022 Contribute to quality training programs for internal teams and external partners. u2022 Assist in risk assessments and continuous improvement initiatives within the clinical and non-clinical quality system. u2022 Provide quality oversight of clinical labeling, including review of label content, artwork, packaging controls, and compliance with regional regulatory requirements. u2022 Partner with crossu2011functional teams to ensure human factors studies are planned, executed, and documented in alignment with regulatory expectations and internal quality standards. u2022 Review human factors protocols, reports, risk assessments, and usability documentation for quality and compliance. u2022 Provide quality oversight and support for nonu2011clinical activities, including review of study protocols, reports, and GLPu2011related documentation to ensure alignment with regulatory expectations and internal quality standards. u2022 Provide quality oversight of Trial Master File (TMF): o Perform routine and risku2011based TMF quality checks to ensure completeness, accuracy, and contemporaneous filing. o Partner with Clinical Operations and CROs to resolve TMF gaps, inconsistencies, or quality issues. o Support TMF health assessments, inspection readiness activities, and ongoing TMF process improvements. Qualifications u2022 Bacheloru2019s degree in life sciences, pharmacy, nursing, or a related field. u2022 3u20135 years of experience in clinical quality assurance, clinical operations, or related GxP roles within the biopharmaceutical or CRO environment. u2022 Strong understanding of ICHu2011GCP, EMA/FDA regulations, and global clinical trial requirements. u2022 Strong understanding of ICHu2011GCP, EMA/FDA regulations, and nonclinical safety study requirements is desirable. u2022 Experience conducting or supporting GCP audits is highly desirable. u2022 Excellent communication, documentation, and interpersonal skills. u2022 Ability to work independently, manage multiple priorities, and collaborate effectively across teams. u2022 Strong analytical and problemu2011solving abilities with a continuous improvement mindset. u2022 Advanced computer capabilities including all MS Office products u2022Competencies: Adaptability, Project Management, Problem Solving, Critical Thinking, Self-Starter, Quality-driven, Written & Verbal Communication skills, Organizational skills, Teamwork & Collaboration, Interpersonal skills u2022Working Conditions: This is a hybrid position based in Xerisu2019 Chicago office and a minimum of three days per week on-site is required. On-site requirement may change at managementu2019s discretion. 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. Up to 50% travel may be required. _The level of the position will be determined based on the selected candidateu2019s qualifications and experience._ #LI-HYBRID _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._ _The anticipated base salary range for this position is $110,000 to $138,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _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._ Job Locations _US-IL-Chicago_ Title _Clinical Quality Assurance (CQA) Manager_ ID _2026-2404_ Category _Quality Assurance_ Type _Full-Time_

Created: 2026-04-29