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 company’s 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

• Assist in the development, review, and maintenance of quality documents, including SOPs, work instructions, quality agreements, and quality plans.• Support the planning, execution, and follow‑up of GCP& GLP audits, including investigator sites, CROs, laboratories, and internal process audits.• Monitor clinical trial activities to ensure compliance with ICH‑GCP, GMP and GLP applicable regulations, and company SOPs.• Partner with Clinical Development, Regulatory Affairs, Pharmacovigilance, device development, labeling, non-clinical and other cross‑functional teams to provide GxP guidance and quality support.• Participate in vendor qualification and ongoing vendor oversight activities as requested.• Track and manage deviations, CAPAs, audit findings, and quality issues to ensure timely and effective resolution.• Support inspection readiness activities and participate in regulatory inspections as needed.• Contribute to quality training programs for internal teams and external partners.• Assist in risk assessments and continuous improvement initiatives within the clinical and non-clinical quality system.• Provide quality oversight of clinical labeling, including review of label content, artwork, packaging controls, and compliance with regional regulatory requirements.• Partner with cross‑functional teams to ensure human factors studies are planned, executed, and documented in alignment with regulatory expectations and internal quality standards.• Review human factors protocols, reports, risk assessments, and usability documentation for quality and compliance.• Provide quality oversight and support for non‑clinical activities, including review of study protocols, reports, and GLP‑related documentation to ensure alignment with regulatory expectations and internal quality standards.• Provide quality oversight of Trial Master File (TMF):    o Perform routine and risk‑based 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

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field.• 3–5 years of experience in clinical quality assurance, clinical operations, or related GxP roles within the biopharmaceutical or CRO environment.• Strong understanding of ICH‑GCP, EMA/FDA regulations, and global clinical trial requirements.• Strong understanding of ICH‑GCP, EMA/FDA regulations, and nonclinical safety study requirements is desirable.• Experience conducting or supporting GCP audits is highly desirable.• Excellent communication, documentation, and interpersonal skills.• Ability to work independently, manage multiple priorities, and collaborate effectively across teams.• Strong analytical and problem‑solving abilities with a continuous improvement mindset.• Advanced computer capabilities including all MS Office products • Competencies: Adaptability, Project Management, Problem Solving, Critical Thinking, Self-Starter, Quality-driven, Written & Verbal Communication skills, Organizational skills, Teamwork & Collaboration, Interpersonal skills

• Working Conditions: This is a hybrid position based in Xeris’ Chicago office and a minimum of three days per week on-site is required. On-site requirement 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 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 candidate’s qualifications and experience.

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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.