Clinical Quality Assurance (CQA) Manager

Xeris Pharmaceuticals•Chicago, IL

8h•Hybrid

About The Position

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.

Requirements

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.
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

Nice To Haves

Strong understanding of ICH‑GCP, EMA/FDA regulations, and nonclinical safety study requirements is desirable.
Experience conducting or supporting GCP audits is highly desirable.

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): Perform routine and risk‑based TMF quality checks to ensure completeness, accuracy, and contemporaneous filing.
Partner with Clinical Operations and CROs to resolve TMF gaps, inconsistencies, or quality issues.
Support TMF health assessments, inspection readiness activities, and ongoing TMF process improvements.