Xeris Pharmaceuticals, Inc. · 5 hours ago
Manager, Quality Control
Chicago, IL
Full-time
Hybrid
Mid, Senior Level
$110K/yr - $160K/yr
5+ years expXeris Pharmaceuticals, Inc. is seeking a Manager of Quality Control to support all aspects of Quality Control for clinical and commercial products. This hands-on role involves managing contract relationships, overseeing testing operations, and ensuring compliance with regulatory standards.
BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
Responsibilities
Manager Quality Control operations at contract sites (CDMO, CMO, Laboratories, etc.). Responsibilities include, but may not be limited to:
Managing contract relationships
Managing Contract Approval Forms, Purchase Orders and updates when required
Participating in vetting and selecting appropriate contract testing labs through the Xeris supplier management process
Supporting material qualification processes
Supporting the coordination of testing of raw, intermediate, and final product through the global supply chain
Managing analytical methods validation and transfer to/from contract testing labs
Overseeing release and stability testing operations at contract sites
Ensuring timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards
Manage/validate SLIMstat software and trend manufacturing/stability data
Participating in the preparation of analytical, testing, and specification sections of regulatory submissions and communications
Adhering to CMC/QC budgets
Support Mid/late Stage clinical and commercial stability programs. Responsibilities include, but may not be limited to:
Supporting the clinical stability programs for Xeris mid-to-late stage products
Supporting the commercial stability programs for Xeris commercial products
Managing stability sample storage and testing at contract sites
Managing API retain and reference standard storage
Participating in the preparation of stability sections for drug substance and drug product sections of regulatory submissions
Qualification
Required
Bachelor's/Master's degree in biology, chemistry, or similar discipline and 5+ years of experience working with pharmaceuticals/biopharmaceuticals, or Ph.D. and 5+ years' experience
A minimum of 5 years in a supervisor or manager role in a GMP pharmaceutical/biopharmaceutical environment, including knowledge of analytical requirements for clinical-phase and commercial products
Experience in Quality Controls and analytical method validation operations
Solid understanding of Quality Systems in support of investigations and quality events
Ability to effectively work with R&D scientists, CMC engineers, Supply Chain, Regulatory Affairs, and Quality Assurance functions
Proficient with Microsoft Word, PowerPoint, Outlook, and Excel, as well as web-based software for various applications
Experience in the use and application of statistical software. For example, SLIM, JMP, etc
Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills
Benefits
Bonus
Equity
Multiple paid time off benefits
Various health insurance options
Retirement benefits
Company
Xeris Pharmaceuticals, Inc.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
201-500 employees
H1B Sponsorship
Xeris Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$548.5MKey Investors
Hayfin Capital ManagementArmistice CapitalDeerfield
2024-03-06Post Ipo Debt· $200M
2022-01-03Post Ipo Equity· $30M
2021-03-11Post Ipo Equity· $27M
Leadership Team
John Shannon
CEO and Director
Kenneth Johnson
Senior Vice President - Clinical Development, Regulatory Affairs, QA and Medical Affairs
Recent News
2026-01-09
The Motley Fool
2026-01-03
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